Last updated: 07/17/2024 17:48:05
GR270773 In The Treatment Of Suspected Or Confirmed Gram-Negative Severe Sepsis In Adults
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Prospective, Randomized, Double-blind, Placebo Controlled, Dose Ranging, Multi-Center Study of the Safety and Efficacy of Three Days Continuous Intravenous Infusion of GR270773 in the Treatment of Suspected or Confirmed Gram-negative Severe Sepsis in Adults
Trial description: The primary objective is to estimate the size of the GR270773 treatment effect on 28-day all-cause mortality for two doses of GR270773 versus placebo in adult subjects with suspected or confirmed Gram-negative severe sepsis. GR270773 will be administered as a three-day continuous intravenous infusion.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Percentage of participants with 28-Day all cause mortality
Timeframe: Day 1 (post-infusion) up to Day 28 Follow-up
Secondary outcomes:
Number of participants with new onset organ failure, regardless of cause, occurring during the 28 days post enrollment in an organ not in failure at enrolment
Timeframe: Baseline (Day 1, pre-infusion) up to Day 28 Follow-up
Number of participants with new onset organ failure of respiratory failure, cardiovascular failure, renal failure and coagulopathy, regardless of cause, occurring during the 28 days post enrollment in an organ not in failure at enrollment
Timeframe: Baseline (Day 1, pre-infusion) up to Day 28 Follow up
Assessment of safety/tolerability by determining the number of participants with any adverse events (AE), serious adverse events (SAE) and fatal SAE
Timeframe: Day 1 (pre-infusion) up to Day 28 Follow-up
Interventions:
Drug: Intravenous GR270773- Phospholipid Emulsion
Other: Placebo
Enrollment:
1415
Observational study model:
Not applicable
Primary completion date:
2007-15-04
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Sepsis
Product
GR270773
Collaborators
Not applicable
Study date(s)
September 2004 to April 2007
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 years - 0 Not applicable
Accepts healthy volunteers
No
- Receiving parenteral antibiotic therapy for a suspected or confirmed Gram-negative infection.
- Have at least one new hypoperfusion abnormality or at least one new onset organ failure resulting from the current septic episode.
- Subject is unlikely to remain in hospital for a minimum of three days (72 hours) following enrollment.
- Subject has neutropenia (e.g., subject recently receiving cytotoxic chemotherapy with absolute neutrophil count <500/mcL or expected to decline to <500/mcL in the next 3 days).
Inclusion and exclusion criteria
Inclusion criteria:
- Receiving parenteral antibiotic therapy for a suspected or confirmed Gram-negative infection.
- Have at least one new hypoperfusion abnormality or at least one new onset organ failure resulting from the current septic episode.
- Must be available and able to receive the first dose of study medication no more than 12 hours after the confirmation of a new hypoperfusion abnormality or new onset organ failure and within 36 hours after the initiation of new parenteral antibacterial therapy for the suspected or confirmed Gram-negative infection believed to be responsible for this episode of sepsis.
Exclusion criteria:
- Subject is unlikely to remain in hospital for a minimum of three days (72 hours) following enrollment.
- Subject has neutropenia (e.g., subject recently receiving cytotoxic chemotherapy with absolute neutrophil count <500/mcL or expected to decline to <500/mcL in the next 3 days).
- Subject has known active hemolytic disease, immune hemolytic anemias, hemoglobinopathies (sickle cell anemia and thalassemia major).
- Subject has a known bone marrow disorder of inadequate red cell production (eg, aplastic anemia, myelodysplasia).
- Subject is at increased risk of complications from GR270773-related hemolysis due to the inability to increase cardiac function sufficiently to meet the demands for oxygen delivery.
- Subject has a baseline hemoglobin (measured after adequate volume resuscitation) <9.0 g/dL (5.59 mmol/L).
- Subject is currently being treated with XIGRIS (Drotrecogin alfa (activated)) or its use is considered imminent (ie., a decision to treat with XIGRIS has been made).
- Subject has a history of allergic reaction to eggs (or egg products), soybeans, INTRALIPID, or any component of GR270773.
- Subject has been designated as 'not full support do not resuscitate' (DNR), or other equivalent status which prohibits the use of life supporting interventions (e.g., mechanical ventilation, dialysis/hemofiltration, or others) thereby limiting the treatment options available. Note: Subjects with advanced directives prohibiting only chest compression (CPR) are eligible for the study.
- Subject has preexisting severe liver disease such as cirrhosis, primary biliary cirrhosis or known preexisting Child-Pugh class B or C liver dysfunction.
- Subject is moribund (a state in which death is perceived to be imminent) or has a life expectancy of less than 3 months due to an underlying disease.
- Subject is currently receiving one of the following prohibited concomitant medications; parenteral nutrition supplements containing lipid emulsions (e.g., INTRALIPID), amphotericin, liposomal amphotericin, or amphotericin B lipid complex.
Trial location(s)
Location
GSK Investigational Site
Tucson, Arizona, United States, 85711
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Stanford, California, United States, 94305
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G42 9TY
Status
Study Complete
Location
GSK Investigational Site
Salem, Virginia, United States, 24153
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46280
Status
Study Complete
Location
GSK Investigational Site
Erlangen, Bayern, Germany, 91054
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Oak Park, Illinois, United States, 60302
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80218
Status
Study Complete
Location
GSK Investigational Site
Torrance, California, United States, 90509
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bellingham, Washington, United States, 98226
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Los Angeles, California, United States, 90089
Status
Study Complete
Location
GSK Investigational Site
Tacoma, Washington, United States, 98405
Status
Study Complete
Location
GSK Investigational Site
Flint, Michigan, United States, 48503
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Goettingen, Niedersachsen, Germany, 37075
Status
Study Complete
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29605
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bielefeld, Nordrhein-Westfalen, Germany, 33617
Status
Study Complete
Location
GSK Investigational Site
Bonn, Nordrhein-Westfalen, Germany, 53111
Status
Study Complete
Location
GSK Investigational Site
Syracuse, New York, United States, 13210
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Waterbury, Connecticut, United States, 06708
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Camden, New Jersey, United States, 08103-1489
Status
Study Complete
Location
GSK Investigational Site
Tucson, Arizona, United States, 85724
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bethlehem, Pennsylvania, United States, 18018
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Atlantis, Florida, United States, 33462
Status
Study Complete
Location
GSK Investigational Site
Toronto, Ontario, Canada, M4N 3M5
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ann Arbor, Michigan, United States, 48109
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Albany, New York, United States, 12208
Status
Study Complete
Location
GSK Investigational Site
Chattanooga, Tennessee, United States, 37403
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Honolulu, Hawaii, United States, 96813
Status
Study Complete
Location
GSK Investigational Site
Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZD
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63110
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Durham, North Carolina, United States, 27705
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80919
Status
Study Complete
Location
GSK Investigational Site
Everett, Washington, United States, 98201
Status
Study Complete
Location
GSK Investigational Site
Livingston, West Lothian, United Kingdom, EH54 6PP
Status
Study Complete
Location
GSK Investigational Site
Des Moines, Iowa, United States, 50314
Status
Study Complete
Location
GSK Investigational Site
Sheffield, United Kingdom, S10 2JF
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Auckland Park, Johannesburg, South Africa, 2006
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Sherbrooke, Québec, Canada, J1H 5N4
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Orlando, Florida, United States, 32803
Status
Study Complete
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51109
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Greifswald, Mecklenburg-Vorpommern, Germany, 17487
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15261
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Sacramento, California, United States, 95819
Status
Study Complete
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, 1432
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Melbourne, Florida, United States, 32901
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19140
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bronx, New York, United States, 10467-2490
Status
Study Complete
Location
GSK Investigational Site
Richmond, Virginia, United States, 23249
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33316
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Kansas City, Kansas, United States, 66160
Status
Study Complete
Location
GSK Investigational Site
Wuppertal, Nordrhein-Westfalen, Germany, 42283
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Study Complete
Location
GSK Investigational Site
Muenchen, Bayern, Germany, 80804
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Norfolk, Virginia, United States, 23507
Status
Study Complete
Location
GSK Investigational Site
Šempeter pri Novi Gorici, Slovenia
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Walnut Creek, California, United States, 94598
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84132
Status
Study Complete
Location
GSK Investigational Site
Toronto, Ontario, Canada, M5T 2S8
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37232
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73104
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Augsburg, Bayern, Germany, 86156
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Marshfield, Wisconsin, United States, 54449
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02114
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95816
Status
Study Complete
Location
GSK Investigational Site
Bloemfontein, South Africa, 9300
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ottawa, Ontario, Canada, K1Y 4E9
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New York, New York, United States, 10021
Status
Study Complete
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 1C6
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Maywood, Illinois, United States, 60153
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21237-3998
Status
Terminated/Withdrawn
Location
GSK Investigational Site
East Lansing, Michigan, United States, 48824
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Moron-Provincia de Buenos Aires, Argentina, 1709
Status
Recruiting
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Fullerton, California, United States, 92835
Status
Study Complete
Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53215
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lubbock, Texas, United States, 79430-8183
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Denver, Colorado, United States, 80210
Status
Study Complete
Location
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18057
Status
Study Complete
Location
GSK Investigational Site
Nedlands, Victoria, Australia, 6009
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Juan, Puerto Rico, Puerto Rico, 00921
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Knoxville, Tennessee, United States, 37920
Status
Study Complete
Location
GSK Investigational Site
São Paulo, São Paulo, Brazil, 05651-901
Status
Study Complete
Location
GSK Investigational Site
Augusta, Georgia, United States, 30909
Status
Study Complete
Location
GSK Investigational Site
Jackson, Mississippi, United States, 39202
Status
Study Complete
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Stamford, Connecticut, United States, 06902
Status
Study Complete
Location
GSK Investigational Site
Bonn, Nordrhein-Westfalen, Germany, 53127
Status
Study Complete
Location
GSK Investigational Site
Providence, Rhode Island, United States, 02903
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
Status
Study Complete
Location
GSK Investigational Site
Honolulu, Hawaii, United States, 96816
Status
Study Complete
Location
GSK Investigational Site
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Status
Study Complete
Location
GSK Investigational Site
Orange, California, United States, 92868
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Monroeville, Pennsylvania, United States, 15146
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Fort Worth, Texas, United States, 76104
Status
Study Complete
Location
GSK Investigational Site
Duluth, Minnesota, United States, 55805
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Toronto, Ontario, Canada, M5G 2N2
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chicago, Illinois, United States, 60611
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Greenville, North Carolina, United States, 27858
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24105
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80204
Status
Study Complete
Location
GSK Investigational Site
Saint John, New Brunswick, Canada, E2M 3W5
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rome, Georgia, United States, 30165
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Naperville, Illinois, United States, 60540
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85006
Status
Study Complete
Location
GSK Investigational Site
Detroit, Michigan, United States, 48202
Status
Study Complete
Location
GSK Investigational Site
Bad Berka, Thueringen, Germany, 99437
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ostrava - Poruba, Czech Republic, 708 52
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Columbus, Ohio, United States, 43210
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Dallas, Texas, United States, 75390-9113
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Toledo, Ohio, United States, 43614-5809
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lackland Air Force Base, Texas, United States, 78236-5300
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Sarasota, Florida, United States, 34239
Status
Study Complete
Location
GSK Investigational Site
Edmonton, Alberta, Canada, T6G 2B7
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Calgary, Alberta, Canada, T2V 1P9
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Calgary, Alberta, Canada, T2N 2T9
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21201
Status
Terminated/Withdrawn
Location
GSK Investigational Site
St Leonards, New South Wales, Australia, 2065
Status
Study Complete
Location
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19055
Status
Study Complete
Location
GSK Investigational Site
Ribeirão Preto, São Paulo, Brazil, 14085-000
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19141
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Newark, Delaware, United States, 19718
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New York, New York, United States, 10065
Status
Study Complete
Location
GSK Investigational Site
Buffalo, New York, United States, 14215
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30659
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Fremantle, Western Australia, Australia, 6959
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68167
Status
Study Complete
Location
GSK Investigational Site
North Chicago, Illinois, United States, 60064
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Burlington, Vermont, United States, 05401
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35294
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Victoria, British Columbia, Canada, V8R 1J8
Status
Study Complete
Location
GSK Investigational Site
Luebeck, Schleswig-Holstein, Germany, 23538
Status
Study Complete
Location
GSK Investigational Site
Bentonville, Arkansas, United States, 71712
Status
Study Complete
Location
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69126
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Johannesburg, Gauteng, South Africa, 2193
Status
Study Complete
Location
GSK Investigational Site
Neubrandenburg, Mecklenburg-Vorpommern, Germany, 17036
Status
Study Complete
Location
GSK Investigational Site
Wigan, Lancashire, United Kingdom, WN6 9EP
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Decatur, Georgia, United States, 30033
Status
Study Complete
Location
GSK Investigational Site
Columbia, South Carolina, United States, 29203
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60612
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Greensboro, North Carolina, United States, 27410
Status
Study Complete
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V6Z 1Y6
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40536-0293
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37212
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bay Pines, Florida, United States, 33744
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, 1842
Status
Recruiting
Location
GSK Investigational Site
Reading, Berkshire, United Kingdom, RG1 7AN
Status
Study Complete
Location
GSK Investigational Site
Honolulu, Hawaii, United States, 96817
Status
Study Complete
Location
GSK Investigational Site
Huntington, West Virginia, United States, 25701-1693
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Houston, Texas, United States, 77030
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Somers Point, New Jersey, United States, 08244
Status
Study Complete
Location
GSK Investigational Site
Greenfield Park, Québec, Canada, J4V 2H1
Status
Study Complete
Location
GSK Investigational Site
Sainte-Foy, Québec, Canada, G1V 4G2
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29425
Status
Study Complete
Location
GSK Investigational Site
Kalamazoo, Michigan, United States, 49048
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pawtucket, Rhode Island, United States, 02860
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Wichita, Kansas, United States, 67214
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02115
Status
Study Complete
Location
GSK Investigational Site
Shreveport, Louisiana, United States, 77103
Status
Study Complete
Location
GSK Investigational Site
Tuen Mun, New Territories, Hong Kong
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Fresno, California, United States, 93720
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ludwigshafen, Rheinland-Pfalz, Germany, 67063
Status
Study Complete
Location
GSK Investigational Site
Fort Collins, Colorado, United States, 80524
Status
Study Complete
Location
GSK Investigational Site
Victoria, British Columbia, Canada, V8Z 6R5
Status
Study Complete
Location
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G11 6NT
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Piscataway, New Jersey, United States, 08854
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Seattle, Washington, United States, 98101
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Villa Sarmiento-Haedo, Buenos Aires, Argentina, 1706
Status
Study Complete
Location
GSK Investigational Site
New Albany, Indiana, United States, 47510
Status
Study Complete
Location
GSK Investigational Site
Liverpool, Merseyside, United Kingdom, L7 8XP
Status
Study Complete
Location
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G51 4TF
Status
Study Complete
Location
GSK Investigational Site
Saskatoon, Saskatchewan, Canada, S7N 0W8
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10029
Status
Study Complete
Location
GSK Investigational Site
Bronx, New York, United States, 10461
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Marseille cedex 9, France, 13274
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Chicago, Illinois, United States, 60612-7230
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Loma Linda, California, United States, 92534
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New Port Richey, Florida, United States, 34655
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Nuernberg, Bayern, Germany, 90340
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Slidell, Louisiana, United States, 70458
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70806
Status
Terminated/Withdrawn
Location
GSK Investigational Site
New Orleans, Louisiana, United States, 70112
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Washington, District of Columbia, United States, 20010
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Jose, California, United States, 95119
Status
Study Complete
Location
GSK Investigational Site
New Westminster, British Columbia, Canada, V3L 3W4
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bath, Somerset, United Kingdom, BA1 3NG
Status
Study Complete
Location
GSK Investigational Site
Peoria, Illinois, United States, 62526
Status
Study Complete
Location
GSK Investigational Site
Wismar, Mecklenburg-Vorpommern, Germany, 23966
Status
Study Complete
Location
GSK Investigational Site
Lynchburg, Virginia, United States, 24501
Status
Study Complete
Location
GSK Investigational Site
Chicoutimi, Québec, Canada, G7H 5H6
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Corvallis, Oregon, United States, 97330
Status
Study Complete
Location
GSK Investigational Site
Springfield, Massachusetts, United States, 01199
Status
Study Complete
Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53226
Status
Terminated/Withdrawn
Study documents
Scientific result summary
Available language(s): English
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-15-04
Actual study completion date
2007-15-04
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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Access to clinical trial data by researchers
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