Last updated: 11/04/2018 06:06:53
Evaluation of GW406381 in treating Adults with Osteoarthritis Of The Knee
GSK study ID
CXA30007
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2007-15-09
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
GSK Investigational Site
Concinnati, Ohio, United States, 45219
Status
Study Complete
Location
GSK Investigational Site
Evansville, Indiana, United States, 47714
Status
Study Complete
Location
GSK Investigational Site
Drummondville, Québec, Canada, J2B 1H8
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89128
Status
Study Complete
Location
GSK Investigational Site
Peoria, Arizona, United States, 85381 - 4828
Status
Study Complete
Location
GSK Investigational Site
Upland, California, United States, 91786
Status
Study Complete
Location
GSK Investigational Site
Stuart, Florida, United States, 34996
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Walnut Creek, California, United States, 94598
Status
Study Complete
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87108
Status
Study Complete
Location
GSK Investigational Site
Endwell, New York, United States, 13760
Status
Study Complete
Location
GSK Investigational Site
Lansing, Michigan, United States, 48910
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84121
Status
Study Complete
Location
GSK Investigational Site
Rochester, New York, United States, 14609
Status
Study Complete
Location
GSK Investigational Site
Duncansville, Pennsylvania, United States, 16635
Status
Study Complete
Location
GSK Investigational Site
Gallipolis, Ohio, United States, 45631
Status
Terminated/Withdrawn
Location
GSK Investigational Site
La Roca del Valles (Barcelona), Spain, 08430
Status
Study Complete
Location
GSK Investigational Site
Kelowna, British Columbia, Canada, V1Y 2H4
Status
Study Complete
Location
GSK Investigational Site
Vancouver, Washington, United States, 98664
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Portland, Oregon, United States, 97216
Status
Study Complete
Location
GSK Investigational Site
Billings, Montana, United States, 59101
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85015
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35205
Status
Study Complete
Location
GSK Investigational Site
Libertyville, Illinois, United States, 60048
Status
Study Complete
Location
GSK Investigational Site
West Yarmouth, Massachusetts, United States, 02673
Status
Study Complete
Location
GSK Investigational Site
Trumbull, Connecticut, United States, 06611
Status
Study Complete
Location
GSK Investigational Site
Munfordville, Kentucky, United States, 42765
Status
Study Complete
Location
GSK Investigational Site
Palm Harbor, Florida, United States, 34684
Status
Study Complete
Location
GSK Investigational Site
Racine, Wisconsin, United States, 53404
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Largo, Florida, United States, 33773
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Niagara Falls, Ontario, Canada, L2E 6A6
Status
Study Complete
Location
GSK Investigational Site
Beverly Hills, California, United States, 90211
Status
Study Complete
Location
GSK Investigational Site
Rochester, New York, United States, 14618
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Status
Study Complete
Location
GSK Investigational Site
Caguas, Puerto Rico, Puerto Rico, 00726
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Fort Worth, Texas, United States, 76104
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Slidell, Louisiana, United States, 70458
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Woodville, South Australia, Australia, 5011
Status
Study Complete
Location
GSK Investigational Site
Mount Pleasant, South Carolina, United States, 29464
Status
Study Complete
Location
GSK Investigational Site
Monroeville, Pennsylvania, United States, 15146
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39104
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27612
Status
Study Complete
Location
GSK Investigational Site
Springfield, Missouri, United States, 65804
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92120
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85012
Status
Study Complete
Location
GSK Investigational Site
Sun City, Arizona, United States, 85351
Status
Study Complete
Location
GSK Investigational Site
Everett, Washington, United States, 98201
Status
Study Complete
Location
GSK Investigational Site
New Tazewell, Tennessee, United States, 37824-1409
Status
Study Complete
Location
GSK Investigational Site
Charlottesville, Virginia, United States, 22911
Status
Study Complete
Location
GSK Investigational Site
Georgetown, Texas, United States, 78626
Status
Study Complete
Location
GSK Investigational Site
Roswell, Georgia, United States, 30075
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Saint John's, Newfoundland and Labrador, Canada, A1C 5B8
Status
Study Complete
Location
GSK Investigational Site
Wheaton, Maryland, United States, 20902
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Decatur, Georgia, United States, 30033
Status
Study Complete
Location
GSK Investigational Site
Huntsville, Alabama, United States, 35801
Status
Study Complete
Location
GSK Investigational Site
Honolulu, Hawaii, United States, 96814
Status
Study Complete
Location
GSK Investigational Site
Victoria, British Columbia, Canada, V8P 5P6
Status
Study Complete
Location
GSK Investigational Site
Wynnewood, Pennsylvania, United States, 19096
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Kippa Ring, Queensland, Australia, 4021
Status
Study Complete
Location
GSK Investigational Site
Penticton, British Columbia, Canada, V2A 3G8
Status
Study Complete
Location
GSK Investigational Site
Toronto, Ontario, Canada, M4N 3M5
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chandler, Québec, Canada, G0C 1K0
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Englewood, New Jersey, United States, 07631
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
New Orleans, Louisiana, United States, 70115
Status
Study Complete
Location
GSK Investigational Site
Scottsdale, Arizona, United States, 85251
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
Status
Study Complete
Location
GSK Investigational Site
Clearwater, Florida, United States, 33761
Status
Study Complete
Location
GSK Investigational Site
Santa Monica, California, United States, 90048
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63108
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Murrells Inlet, South Carolina, United States, 29576
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35209
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Montgomery, Alabama, United States, 36106
Status
Study Complete
Location
GSK Investigational Site
Hampton, South Carolina, United States, 29924
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19115
Status
Study Complete
Location
GSK Investigational Site
Melbourne, Florida, United States, 32901
Status
Study Complete
Location
GSK Investigational Site
Darlinghurst, New South Wales, Australia, 2010
Status
Study Complete
Location
GSK Investigational Site
Trois Rivières, Québec, Canada, G8T 7A1
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29406
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92128
Status
Study Complete
Location
GSK Investigational Site
Bristol, Tennessee, United States, 37620
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Palm Desert, California, United States, 92260
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89103
Status
Study Complete
Location
GSK Investigational Site
Newport News, Virginia, United States, 23606
Status
Study Complete
Location
GSK Investigational Site
Tulsa, Oklahoma, United States, 74135
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Manlius, New York, United States, 13104
Status
Study Complete
Location
GSK Investigational Site
Richardson, Texas, United States, 75080
Status
Study Complete
Location
GSK Investigational Site
Carina Heights, Queensland, Australia, 4152
Status
Study Complete
Location
GSK Investigational Site
Fort Myers, Florida, United States, 33907
Status
Study Complete
Location
GSK Investigational Site
Greensboro, North Carolina, United States, 27401
Status
Study Complete
Location
GSK Investigational Site
West Monroe, Louisiana, United States, 71291
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85023
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63117
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92103-6204
Status
Study Complete
Location
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Mayfield Village, Ohio, United States, 44143
Status
Study Complete
Location
GSK Investigational Site
Berlin, New Jersey, United States, 08009
Status
Study Complete
Location
GSK Investigational Site
Coral Gables, Florida, United States, 33134
Status
Study Complete
Location
GSK Investigational Site
Muenchen, Bayern, Germany, 81667
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pembroke Pines, Florida, United States, 33024
Status
Study Complete
Location
GSK Investigational Site
Moncton, New Brunswick, Canada, E1G 1A7
Status
Study Complete
Location
GSK Investigational Site
Anaheim, California, United States, 92801
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21208
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35215
Status
Study Complete
Location
GSK Investigational Site
Greer, South Carolina, United States, 29651
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21239
Status
Study Complete
Location
GSK Investigational Site
San Juan, Puerto Rico, Puerto Rico, 00926
Status
Study Complete
Location
GSK Investigational Site
Carolina, Puerto Rico, Puerto Rico, 00983
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
Mechanicsburg, Pennsylvania, United States, 17055
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98166
Status
Study Complete
Location
GSK Investigational Site
Jackson, Tennessee, United States, 38305
Status
Study Complete
Location
GSK Investigational Site
Springfield, Illinois, United States, 62704
Status
Study Complete
Location
GSK Investigational Site
Miami, Florida, United States, 33156
Status
Terminated/Withdrawn
Location
GSK Investigational Site
West Reading, Pennsylvania, United States, 19611
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10024
Status
Study Complete
Location
GSK Investigational Site
Henderson, Nevada, United States, 89014
Status
Study Complete
Location
GSK Investigational Site
Honolulu, Hawaii, United States, 96816
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89119
Status
Study Complete
Location
GSK Investigational Site
Dover, New Hampshire, United States, 03820
Status
Study Complete
Location
GSK Investigational Site
Memphis, Tennessee, United States, 38119
Status
Study Complete
Location
GSK Investigational Site
Columbus, Ohio, United States, 43210
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Wichita Falls, Texas, United States, 76309
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97219
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63126
Status
Study Complete
Location
GSK Investigational Site
Pointe-Claire, Québec, Canada, H9R 4S3
Status
Study Complete
Location
GSK Investigational Site
Saskatoon, Saskatchewan, Canada, S7N 0W8
Status
Study Complete
Location
GSK Investigational Site
Sugar Land, Texas, United States, 77478
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Campdevánol (Gerona), Spain, 17530
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Cleveland, Ohio, United States, 44106
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, C1121ABE
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Johnson City, New York, United States, 13790
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hickory, North Carolina, United States, 28601
Status
Terminated/Withdrawn
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
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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