Last updated: 11/04/2018 06:06:53

Evaluation of GW406381 in treating Adults with Osteoarthritis Of The Knee

GSK study ID
CXA30007
Clinicaltrials.gov ID
NCT00120900
See results summary
EudraCT ID
2005-000149-12
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Phase III, 12-week, Multicentre, Double-blind, Double-dummy, Randomised, Placebo and Active Comparator-Controlled, Parallel Group study to investigate the Efficacy and Safety of GW406381 1mg, 5mg, 10mg, 25mg and 50mg administered orally once daily, in adults with Osteoarthritis of the knee.
Trial description: This study was designed to evaluate the effectiveness of GW406381 (a COX-2 inhibitor) in treating the signs and symptoms of osteoarthritis of the knee.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Change from Baseline to week 12 in Western Ontario and McMasters Universities osteoarthritis (OA) Index (WOMAC) pain subscale score

Timeframe: Baseline (Day 1) and Week 12

Change from Baseline to week 12 in WOMAC physical function subscale score

Timeframe: Baseline (Day 1) and Week 12

Change from Baseline to week 12 in the patient global assessment of arthritis condition

Timeframe: Baseline (Day 1) and Week 12

Secondary outcomes:

Change from Baseline in WOMAC pain subscale score at each scheduled visit

Timeframe: Baseline (Day 1), Week 2, Week 4, Week 8 and Week 12

Change from Baseline in WOMAC pain subscale question 1 (pain walking on a flat surface) score at each scheduled visit

Timeframe: Baseline (Day 1), Week 2, 4, 8 and 12

Change from Baseline in WOMAC stiffness subscale score at each scheduled visit

Timeframe: Baseline (Day 1), Week 2, 4, 8 and 12

Change from Baseline in WOMAC physical function subscale score at each scheduled visit

Timeframe: Baseline (Day 1), Week 2, 4, 8 and 12

Change from Baseline in participant’s global assessment of arthritis condition at each scheduled visit

Timeframe: Baseline (Day 1), Week 2, 4, 8 and 12

Change from Baseline in physician’s global assessment of arthritis condition at each scheduled visit

Timeframe: Baseline (Day 1), Week 2, 4, 8 and 12

Percentage of responders as measured by the Osteoarthritis Research Society International (OARSI) responder index (using the OMERACT:OARSI definition) at each scheduled visit

Timeframe: Week 2, 4, 8 and 12

Number of participants discontinued due to lack of efficacy

Timeframe: Up to 12 Weeks

Percentage of participants who received supplementary analgesic therapy

Timeframe: Up to Week 12

Change in the Short Form-36 (SF-36v2) Health Status total and subscale scores between Baseline and the end of treatment (or early withdrawal)

Timeframe: Baseline (Day 1) and Week 12

Psychometrical test and validation of the amended Patient Satisfaction with Pain Medication Questionnaire (PMQ).

Timeframe: Up to Week 12

Change between Baseline and end of treatment (or early withdrawal) in the European Quality of Life -5 Dimensions Proxy version (EQ- 5D) scale total score-Thermometer score

Timeframe: Baseline (Day 1) and Week 12

Change between baseline and end of treatment (or early withdrawal) in the EQ - 5D utility score using the European population utility tariff

Timeframe: Baseline (Day 1) and Week 12

Interventions:
  • Drug: GW406381
    • Enrollment:
    1309
    Primary completion date:
    2007-15-09
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Osteoarthritis, Knee
    Product
    GW406381
    Collaborators
    Not applicable
    Study date(s)
    May 2005 to September 2007
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    40+ years
    Accepts healthy volunteers
    No
    • Subjects have a primary diagnosis of osteoarthritis of the knee with symptom duration of at least 3 months.
    • Use pain medication, such as a COX-2 inhibitor or NSAID (non-steroidal anti-inflammatory drug) at least 5 days per week.
    • History of hypersensitivity or intolerance to pain medications.
    • History of gastroduodenal perforations and/or obstructions.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects have a primary diagnosis of osteoarthritis of the knee with symptom duration of at least 3 months.
    • Use pain medication, such as a COX-2 inhibitor or NSAID (non-steroidal anti-inflammatory drug) at least 5 days per week.
    Exclusion criteria:
    • History of hypersensitivity or intolerance to pain medications.
    • History of gastroduodenal perforations and/or obstructions.
    • History of upper GI (gastrointestinal) ulceration within the previous 6 months.
    • History of upper or lower GI bleeding within the previous year.
    • History of inflammatory bowel disease.
    • Currently take sucralfate or misoprostol.
    • Currently taking aspirin daily for the heart.
    • Other restrictions around the use medications apply and would need to be discussed.
    • History of coronary artery disease, (angina, MI) or surgery.
    • History of congestive heart failure or renal artery stenosis.
    • History of stroke or transient ischemic attack.
    • History of uncontrolled hypertension.

    Trial location(s)

    Location
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    Location
    GSK Investigational Site
    Concinnati, Ohio, United States, 45219
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Evansville, Indiana, United States, 47714
    Status
    Study Complete
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    Location
    GSK Investigational Site
    MALMĂ–, Sweden, SE-211 38
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Drummondville, Québec, Canada, J2B 1H8
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Leipzig, Sachsen, Germany, 04229
    Status
    Study Complete
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    Location
    GSK Investigational Site
    North Bay, Ontario, Canada, P1B 2H3
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Clayton, Victoria, Australia, 3168
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ottawa, Ontario, Canada, K1H 1A2
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Las Vegas, Nevada, United States, 89128
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Peoria, Arizona, United States, 85381 - 4828
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Upland, California, United States, 91786
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Stuart, Florida, United States, 34996
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    STOCKHOLM, Sweden, SE-113 60
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Walnut Creek, California, United States, 94598
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Albuquerque, New Mexico, United States, 87108
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Endwell, New York, United States, 13760
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sainte-Foy, Québec, Canada, G1W 4R4
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lansing, Michigan, United States, 48910
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Salt Lake City, Utah, United States, 84121
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Layton, Utah, United States, 84041
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Rochester, New York, United States, 14609
    Status
    Study Complete
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    GSK Investigational Site
    Duncansville, Pennsylvania, United States, 16635
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Gallipolis, Ohio, United States, 45631
    Status
    Terminated/Withdrawn
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    GSK Investigational Site
    La Roca del Valles (Barcelona), Spain, 08430
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mirabel, Québec, Canada, J7J 2K8
    Status
    Study Complete
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    GSK Investigational Site
    Kelowna, British Columbia, Canada, V1Y 2H4
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Vancouver, Washington, United States, 98664
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Portland, Oregon, United States, 97216
    Status
    Study Complete
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    Location
    GSK Investigational Site
    EWIJK, Netherlands, 6644 CL
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Billings, Montana, United States, 59101
    Status
    Study Complete
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    GSK Investigational Site
    Phoenix, Arizona, United States, 85015
    Status
    Study Complete
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    Location
    GSK Investigational Site
    GĂ–TEBORG, Sweden, SE-416 85
    Status
    Study Complete
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    GSK Investigational Site
    Birmingham, Alabama, United States, 35205
    Status
    Study Complete
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    GSK Investigational Site
    Libertyville, Illinois, United States, 60048
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bergen, Norway, N-5068
    Status
    Study Complete
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    GSK Investigational Site
    Hønefoss, Norway, N-3515
    Status
    Study Complete
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    GSK Investigational Site
    Liege, Belgium, 4020
    Status
    Study Complete
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    GSK Investigational Site
    West Yarmouth, Massachusetts, United States, 02673
    Status
    Study Complete
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    GSK Investigational Site
    Tampa, Florida, United States, 33614
    Status
    Study Complete
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    GSK Investigational Site
    Oviedo, Spain, 33006
    Status
    Study Complete
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    GSK Investigational Site
    Trumbull, Connecticut, United States, 06611
    Status
    Study Complete
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    GSK Investigational Site
    La Coruña, Spain, 15006
    Status
    Study Complete
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    GSK Investigational Site
    Munfordville, Kentucky, United States, 42765
    Status
    Study Complete
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    GSK Investigational Site
    Palm Harbor, Florida, United States, 34684
    Status
    Study Complete
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    GSK Investigational Site
    KUNGSBACKA, Sweden, SE-434 35
    Status
    Study Complete
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    GSK Investigational Site
    Ottawa, Ontario, Canada, K2C 3R2
    Status
    Study Complete
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    GSK Investigational Site
    Racine, Wisconsin, United States, 53404
    Status
    Terminated/Withdrawn
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    GSK Investigational Site
    Auckland, New Zealand, 1701
    Status
    Study Complete
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    GSK Investigational Site
    Largo, Florida, United States, 33773
    Status
    Terminated/Withdrawn
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    GSK Investigational Site
    Niagara Falls, Ontario, Canada, L2E 6A6
    Status
    Study Complete
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    GSK Investigational Site
    Beverly Hills, California, United States, 90211
    Status
    Study Complete
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    GSK Investigational Site
    Rochester, New York, United States, 14618
    Status
    Study Complete
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    GSK Investigational Site
    Dresden, Sachsen, Germany, 01067
    Status
    Study Complete
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    GSK Investigational Site
    Santiago de Compostela, Spain, 15706
    Status
    Study Complete
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    GSK Investigational Site
    Maria, Québec, Canada, G0C 1Y0
    Status
    Study Complete
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    GSK Investigational Site
    UPPSALA, Sweden, SE-753 21
    Status
    Study Complete
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    GSK Investigational Site
    Seoul, South Korea, 135-710
    Status
    Study Complete
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    GSK Investigational Site
    Charlotte, North Carolina, United States, 28207
    Status
    Study Complete
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    GSK Investigational Site
    Austin, Texas, United States, 78746
    Status
    Study Complete
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    GSK Investigational Site
    San Juan, Spain
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    Study Complete
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    GSK Investigational Site
    Deland, Florida, United States, 32720
    Status
    Study Complete
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    Tauranga, New Zealand, 3001
    Status
    Study Complete
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    Merksem, Belgium, 2170
    Status
    Study Complete
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    GSK Investigational Site
    Rotorua, New Zealand, 3201
    Status
    Study Complete
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    GSK Investigational Site
    Woodstock, Ontario, Canada, N4S 4G3
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Windsor, Ontario, Canada, N8X 5A6
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Petrer/Alicante, Spain, 03610
    Status
    Study Complete
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    GSK Investigational Site
    LUND, Sweden, SE-222 21
    Status
    Study Complete
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    GSK Investigational Site
    Oklahoma City, Oklahoma, United States, 73112
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Douglas, Queensland, Australia, 4814
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hamburg, Hamburg, Germany, 20249
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Caguas, Puerto Rico, Puerto Rico, 00726
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Fort Worth, Texas, United States, 76104
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Christchurch, New Zealand, 8001
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Slidell, Louisiana, United States, 70458
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Hamilton, Ontario, Canada, L8N 2B6
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Woodville, South Australia, Australia, 5011
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mount Pleasant, South Carolina, United States, 29464
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    Study Complete
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    Location
    GSK Investigational Site
    Monroeville, Pennsylvania, United States, 15146
    Status
    Terminated/Withdrawn
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    GSK Investigational Site
    Magdeburg, Sachsen-Anhalt, Germany, 39104
    Status
    Study Complete
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    GSK Investigational Site
    Granada, Spain, 18012
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    Study Complete
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    Location
    GSK Investigational Site
    Raleigh, North Carolina, United States, 27612
    Status
    Study Complete
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    GSK Investigational Site
    Springfield, Missouri, United States, 65804
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Leipzig, Sachsen, Germany, 04107
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    Study Complete
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    Location
    GSK Investigational Site
    San Diego, California, United States, 92120
    Status
    Study Complete
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    Phoenix, Arizona, United States, 85012
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    Study Complete
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    GSK Investigational Site
    Merida, Spain, 6800
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    Study Complete
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    GSK Investigational Site
    Sun City, Arizona, United States, 85351
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    Study Complete
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    GSK Investigational Site
    Antwerpen, Belgium, 2020
    Status
    Study Complete
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    GSK Investigational Site
    Everett, Washington, United States, 98201
    Status
    Study Complete
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    GSK Investigational Site
    New Tazewell, Tennessee, United States, 37824-1409
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    Study Complete
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    GSK Investigational Site
    Charlottesville, Virginia, United States, 22911
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    Study Complete
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    GSK Investigational Site
    Georgetown, Texas, United States, 78626
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    Location
    GSK Investigational Site
    Roswell, Georgia, United States, 30075
    Status
    Terminated/Withdrawn
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    GSK Investigational Site
    Baracaldo/Vizcaya, Spain, 48903
    Status
    Study Complete
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    GSK Investigational Site
    Saint John's, Newfoundland and Labrador, Canada, A1C 5B8
    Status
    Study Complete
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    GSK Investigational Site
    Berlin, Berlin, Germany, 12163
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    Study Complete
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    GSK Investigational Site
    Wheaton, Maryland, United States, 20902
    Status
    Terminated/Withdrawn
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    GSK Investigational Site
    Decatur, Georgia, United States, 30033
    Status
    Study Complete
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    GSK Investigational Site
    Daegu, South Korea, 705-718
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    Study Complete
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    Location
    GSK Investigational Site
    Huntsville, Alabama, United States, 35801
    Status
    Study Complete
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    GSK Investigational Site
    Honolulu, Hawaii, United States, 96814
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Granby, Québec, Canada, J2G 8Z9
    Status
    Study Complete
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    GSK Investigational Site
    Szolnok, Hungary, 5000
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    Study Complete
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    GSK Investigational Site
    Victoria, British Columbia, Canada, V8P 5P6
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    Study Complete
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    GSK Investigational Site
    Wynnewood, Pennsylvania, United States, 19096
    Status
    Terminated/Withdrawn
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    GSK Investigational Site
    Dallas, Texas, United States, 75234
    Status
    Study Complete
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    GSK Investigational Site
    Mexico, Mexico, 06700
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    Study Complete
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    GSK Investigational Site
    Truro, Nova Scotia, Canada, B2N 1L2
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    Study Complete
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    GSK Investigational Site
    Centelles, Spain
    Status
    Study Complete
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    GSK Investigational Site
    Kippa Ring, Queensland, Australia, 4021
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    GSK Investigational Site
    Oviedo, Spain
    Status
    Study Complete
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    GSK Investigational Site
    Winnipeg, Manitoba, Canada, R3A 1M3
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    GSK Investigational Site
    Penticton, British Columbia, Canada, V2A 3G8
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    Study Complete
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    GSK Investigational Site
    Hamar, Norway, 2317
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Toronto, Ontario, Canada, M4N 3M5
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Oslo, Norway, N-0370
    Status
    Study Complete
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    Location
    GSK Investigational Site
    HELSINGBORG, Sweden, SE-252 78
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    Study Complete
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    Location
    GSK Investigational Site
    Chandler, Québec, Canada, G0C 1K0
    Status
    Terminated/Withdrawn
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    GSK Investigational Site
    Englewood, New Jersey, United States, 07631
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    GSK Investigational Site
    Spartanburg, South Carolina, United States, 29303
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    GSK Investigational Site
    New Orleans, Louisiana, United States, 70115
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    GSK Investigational Site
    Berlin, Berlin, Germany, 13125
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    Study Complete
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    GSK Investigational Site
    Scottsdale, Arizona, United States, 85251
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    GSK Investigational Site
    Indianapolis, Indiana, United States, 46202
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    GSK Investigational Site
    Clearwater, Florida, United States, 33761
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    GSK Investigational Site
    Wichita, Kansas, United States, 67207
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    Study Complete
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    GSK Investigational Site
    Medford, Oregon, United States, 97504
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    Study Complete
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    GSK Investigational Site
    Lier, Norway, 3400
    Status
    Study Complete
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    GSK Investigational Site
    Guadalajara, Jalisco, Mexico, 44280
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    Study Complete
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    GSK Investigational Site
    Santa Monica, California, United States, 90048
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    Study Complete
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    GSK Investigational Site
    DE BILT, Netherlands, 3731 DN
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    Study Complete
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    Location
    GSK Investigational Site
    St. Louis, Missouri, United States, 63108
    Status
    Terminated/Withdrawn
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    GSK Investigational Site
    Mexico, D.F., Mexico, 06720
    Status
    Terminated/Withdrawn
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    GSK Investigational Site
    Murrells Inlet, South Carolina, United States, 29576
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    Terminated/Withdrawn
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    GSK Investigational Site
    Birmingham, Alabama, United States, 35209
    Status
    Terminated/Withdrawn
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    GSK Investigational Site
    Montgomery, Alabama, United States, 36106
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    Study Complete
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    GSK Investigational Site
    Bruxelles, Belgium, 1040
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    GSK Investigational Site
    Hampton, South Carolina, United States, 29924
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    Philadelphia, Pennsylvania, United States, 19115
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    GSK Investigational Site
    Melbourne, Florida, United States, 32901
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    Study Complete
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    GSK Investigational Site
    Tulsa, Oklahoma, United States, 74104
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    Study Complete
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    GSK Investigational Site
    Darlinghurst, New South Wales, Australia, 2010
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Trois Rivières, Québec, Canada, G8T 7A1
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    Study Complete
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    GSK Investigational Site
    Charleston, South Carolina, United States, 29406
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    GSK Investigational Site
    San Diego, California, United States, 92128
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    Study Complete
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    GSK Investigational Site
    Sainte-Foy, Québec, Canada, G1V 1V6
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    Study Complete
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    Location
    GSK Investigational Site
    Bristol, Tennessee, United States, 37620
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Ă–rebro, Sweden, SE-701 46
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Palm Desert, California, United States, 92260
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    Study Complete
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    GSK Investigational Site
    Las Vegas, Nevada, United States, 89103
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    Study Complete
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    GSK Investigational Site
    Newport News, Virginia, United States, 23606
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    Study Complete
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    GSK Investigational Site
    Tulsa, Oklahoma, United States, 74135
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Ocala, Florida, United States, 34474
    Status
    Study Complete
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    GSK Investigational Site
    Manlius, New York, United States, 13104
    Status
    Study Complete
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    GSK Investigational Site
    Richardson, Texas, United States, 75080
    Status
    Study Complete
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    GSK Investigational Site
    Carina Heights, Queensland, Australia, 4152
    Status
    Study Complete
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    GSK Investigational Site
    Fort Myers, Florida, United States, 33907
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    Greensboro, North Carolina, United States, 27401
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    West Monroe, Louisiana, United States, 71291
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    Phoenix, Arizona, United States, 85023
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    Sherbrooke, Québec, Canada, J1H 1Z1
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    Ishoj, Denmark, 2635
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    HEERLEN, Netherlands, 6416 EG
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    St. Louis, Missouri, United States, 63117
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    San Diego, California, United States, 92103-6204
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Jonesboro, Arkansas, United States, 72401
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Lima, Lima, Peru, Lima 27
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Little Rock, Arkansas, United States, 72205
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mayfield Village, Ohio, United States, 44143
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Berlin, New Jersey, United States, 08009
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Coral Gables, Florida, United States, 33134
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bruxelles, Belgium, 1200
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Brampton, Ontario, Canada, L6T 3T1
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Toronto, Ontario, Canada, M4S 1Y2
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Muenchen, Bayern, Germany, 81667
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Pembroke Pines, Florida, United States, 33024
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Moncton, New Brunswick, Canada, E1G 1A7
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bruxelles, Belgium, 1070
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Anaheim, California, United States, 92801
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Malvern, Victoria, Australia, 3144
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hamburg, Hamburg, Germany, 22143
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Baltimore, Maryland, United States, 21208
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35215
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Greer, South Carolina, United States, 29651
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Baltimore, Maryland, United States, 21239
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Juan, Puerto Rico, Puerto Rico, 00926
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Carolina, Puerto Rico, Puerto Rico, 00983
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Valencia, Spain, 46017
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mississauga, Ontario, Canada, L5M 2V8
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St. Louis, Missouri, United States, 63141
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mechanicsburg, Pennsylvania, United States, 17055
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Seattle, Washington, United States, 98166
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Jackson, Tennessee, United States, 38305
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Springfield, Illinois, United States, 62704
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Miami, Florida, United States, 33156
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Miami, Florida, United States, 33173
    Status
    Study Complete
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    Location
    GSK Investigational Site
    West Reading, Pennsylvania, United States, 19611
    Status
    Study Complete
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    Location
    GSK Investigational Site
    New York, New York, United States, 10024
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tampa, Florida, United States, 33607
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Vic, Spain, 28500
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Henderson, Nevada, United States, 89014
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Honolulu, Hawaii, United States, 96816
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Las Vegas, Nevada, United States, 89119
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Guadalajara, Jalisco, Mexico, 44340
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Dover, New Hampshire, United States, 03820
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Memphis, Tennessee, United States, 38119
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Columbus, Ohio, United States, 43210
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Toronto, Ontario, Canada, M9W 4L6
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Wichita Falls, Texas, United States, 76309
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Charlesbourg, Québec, Canada, G1G 4A2
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mission, Kansas, United States, 66202
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Portland, Oregon, United States, 97219
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kitchener, Ontario, Canada, N2M 5N6
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Barcelona, Spain, 8025
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St. Louis, Missouri, United States, 63126
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pointe-Claire, Québec, Canada, H9R 4S3
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Gatineau, Québec, Canada, J8Y 6S8
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Saskatoon, Saskatchewan, Canada, S7N 0W8
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mons, Belgium, 7000
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 10117
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sugar Land, Texas, United States, 77478
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Dresden, Sachsen, Germany, 01307
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Campdevánol (Gerona), Spain, 17530
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Cleveland, Ohio, United States, 44106
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Ciudad AutĂłnoma de Buenos Aires, Argentina, C1121ABE
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Sherbrooke, Québec, Canada, J1H 4J6
    Status
    Study Complete
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    Location
    GSK Investigational Site
    JOHANNESHOV, Sweden, SE-121 77
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Anyang-Si, South Korea, 431-070
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Johnson City, New York, United States, 13790
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Hickory, North Carolina, United States, 28601
    Status
    Terminated/Withdrawn
    Contact us

    Study documents

    No study documents available.

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2007-15-09
    Actual study completion date
    2007-15-09

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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