GR270773 In The Treatment Of Suspected Or Confirmed Gram-Negative Severe Sepsis In Adults

NCT00089986 | Completed Phase 2 Results

• 1 other identifier: EMD20001
• Study Type: interventional
• Target: 1,415
• Locations: 32 countries
• Sites: 382

Brief Summary

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.

Conditions

Sepsis

Keywords

severe sepsis; septic shock; Gram-negative infection; phospholipid emulsion

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With 28-Day All Cause Mortality

  Mortality was assessed by the number of participants who died between days 1 and 28. A summary of death details was given which included whether the participant died between days 1 and 28, whether the death was related sepsis, cause of death, the source of the information, and whether the cause of death was verified by a death record. Participants who had withdrawn from study and all study assessments and for whom survival at day 28 could not be confirmed was treated as deaths for the primary endpoint. The difference in all-cause 28-day mortality rates for each treatment group versus the placebo group in the ITT Population was calculated as placebo - treatment.

  Day 1 (post-infusion) up to Day 28 Follow-up

Secondary Outcomes (3)

• 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

  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

  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

  Day 1 (pre-infusion) up to Day 28 Follow-up

Interventions

Intravenous GR270773- Phospholipid Emulsion DRUG

Placebo OTHER

Also known as: Matched placebo infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (390)

GSK Investigational Site

Birmingham, Alabama, 35294, United States

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Phoenix, Arizona, 85006, United States

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Tucson, Arizona, 85711, United States

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Tucson, Arizona, 85724, United States

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Bentonville, Arkansas, 71712, United States

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Little Rock, Arkansas, 72205, United States

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Fresno, California, 93720, United States

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Fullerton, California, 92835, United States

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Loma Linda, California, 92534, United States

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Los Angeles, California, 90089, United States

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Orange, California, 92868, United States

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Sacramento, California, 95816, United States

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Sacramento, California, 95819, United States

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San Jose, California, 95119, United States

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Stanford, California, 94305, United States

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Torrance, California, 90509, United States

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Walnut Creek, California, 94598, United States

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Colorado Springs, Colorado, 80919, United States

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Denver, Colorado, 80204, United States

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Denver, Colorado, 80210, United States

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Denver, Colorado, 80218, United States

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Fort Collins, Colorado, 80524, United States

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Stamford, Connecticut, 06902, United States

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Waterbury, Connecticut, 06708, United States

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Newark, Delaware, 19718, United States

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Washington D.C., District of Columbia, 20010, United States

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Atlantis, Florida, 33462, United States

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Bay Pines, Florida, 33744, United States

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Fort Lauderdale, Florida, 33316, United States

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Melbourne, Florida, 32901, United States

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New Port Richey, Florida, 34655, United States

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Ocala, Florida, 34471, United States

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Orlando, Florida, 32803, United States

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Sarasota, Florida, 34239, United States

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Tampa, Florida, 33601, United States

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Atlanta, Georgia, 30342, United States

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Augusta, Georgia, 30909, United States

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Decatur, Georgia, 30033, United States

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Rome, Georgia, 30165, United States

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Honolulu, Hawaii, 96813, United States

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Honolulu, Hawaii, 96816, United States

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Honolulu, Hawaii, 96817, United States

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Chicago, Illinois, 60611, United States

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Chicago, Illinois, 60612-7230, United States

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Chicago, Illinois, 60612, United States

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Maywood, Illinois, 60153, United States

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Naperville, Illinois, 60540, United States

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North Chicago, Illinois, 60064, United States

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Oak Park, Illinois, 60302, United States

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Peoria, Illinois, 62526, United States

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Indianapolis, Indiana, 46280, United States

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New Albany, Indiana, 47510, United States

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Des Moines, Iowa, 50314, United States

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Iowa City, Iowa, 52242, United States

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Kansas City, Kansas, 66160, United States

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Wichita, Kansas, 67214, United States

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Lexington, Kentucky, 40536-0293, United States

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Baton Rouge, Louisiana, 70806, United States

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New Orleans, Louisiana, 70112, United States

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Shreveport, Louisiana, 77103, United States

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Slidell, Louisiana, 70458, United States

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Baltimore, Maryland, 21201, United States

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Baltimore, Maryland, 21237-3998, United States

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Baltimore, Maryland, 21287-5554, United States

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Boston, Massachusetts, 02114, United States

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Boston, Massachusetts, 02115, United States

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Springfield, Massachusetts, 01199, United States

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Ann Arbor, Michigan, 48109, United States

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Detroit, Michigan, 48202, United States

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East Lansing, Michigan, 48824, United States

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Flint, Michigan, 48503, United States

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Kalamazoo, Michigan, 49048, United States

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Duluth, Minnesota, 55805, United States

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Jackson, Mississippi, 39202, United States

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St Louis, Missouri, 63110, United States

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Butte, Montana, 59701, United States

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Camden, New Jersey, 08103-1489, United States

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Piscataway, New Jersey, 08854, United States

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Somers Point, New Jersey, 08244, United States

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Albany, New York, 12208, United States

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Buffalo, New York, 14215, United States

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New York, New York, 10021, United States

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New York, New York, 10029, United States

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New York, New York, 10065, United States

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Syracuse, New York, 13210, United States

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The Bronx, New York, 10461, United States

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The Bronx, New York, 10467-2490, United States

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Durham, North Carolina, 27705, United States

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Greensboro, North Carolina, 27410, United States

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Greenville, North Carolina, 27858, United States

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Winston-Salem, North Carolina, 27103, United States

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Akron, Ohio, 44307, United States

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Columbus, Ohio, 43210, United States

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Columbus, Ohio, 43215, United States

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Toledo, Ohio, 43614-5809, United States

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Oklahoma City, Oklahoma, 73104, United States

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Bend, Oregon, 97701, United States

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Corvallis, Oregon, 97330, United States

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Bethlehem, Pennsylvania, 18018, United States

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Monroeville, Pennsylvania, 15146, United States

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Philadelphia, Pennsylvania, 19140, United States

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Philadelphia, Pennsylvania, 19141, United States

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Pittsburgh, Pennsylvania, 15261, United States

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Pawtucket, Rhode Island, 02860, United States

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Providence, Rhode Island, 02903, United States

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Charleston, South Carolina, 29425, United States

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Columbia, South Carolina, 29203, United States

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Greenville, South Carolina, 29605, United States

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Chattanooga, Tennessee, 37403, United States

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Knoxville, Tennessee, 37920, United States

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Nashville, Tennessee, 37212, United States

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Nashville, Tennessee, 37232, United States

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Dallas, Texas, 75231, United States

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Dallas, Texas, 75390-9113, United States

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Fort Worth, Texas, 76104, United States

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Houston, Texas, 77030, United States

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GSK Investigational Site

Lackland Air Force Base, Texas, 78236-5300, United States

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Lubbock, Texas, 79430-8183, United States

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Salt Lake City, Utah, 84132, United States

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Burlington, Vermont, 05401, United States

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Lynchburg, Virginia, 24501, United States

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Norfolk, Virginia, 23507, United States

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Richmond, Virginia, 23249, United States

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Salem, Virginia, 24153, United States

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Bellingham, Washington, 98226, United States

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Everett, Washington, 98201, United States

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Seattle, Washington, 98101, United States

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Tacoma, Washington, 98405, United States

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Huntington, West Virginia, 25701-1693, United States

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Marshfield, Wisconsin, 54449, United States

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Milwaukee, Wisconsin, 53215, United States

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Milwaukee, Wisconsin, 53226, United States

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Villa Sarmiento-Haedo, Buenos Aires, 1706, Argentina

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Córdoba, Córdoba Province, 5000, Argentina

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Buenos Aires, 1432, Argentina

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Buenos Aires, 1842, Argentina

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Buenos Aires, Argentina

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Ciudad de Buenos Aires, Argentina

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Moron-Provincia de Buenos Aires, 1709, Argentina

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St Leonards, New South Wales, 2065, Australia

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Footscray, Victoria, 3011, Australia

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Heidelberg, Victoria, 3084, Australia

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Nedlands, Victoria, 6009, Australia

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Fremantle, Western Australia, 6959, Australia

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Innsbruck, A-6020, Austria

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Vienna, A-1090, Austria

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Vienna, A-1100, Austria

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Vienna, A-1220, Austria

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Aalst, 9300, Belgium

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Brussels, 1070, Belgium

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Brussels, 1090, Belgium

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Brussels, 1200, Belgium

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Genk, 3600, Belgium

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Ghent, 9000, Belgium

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Leuven, 3000, Belgium

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Ottignies, 1340, Belgium

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Yvoir, 5530, Belgium

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GSK Investigational Site

Curitiba, Paraná, 80069-900, Brazil

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Ribeirão Preto, São Paulo, 14085-000, Brazil

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GSK Investigational Site

São Paulo, 05651-901, Brazil

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Calgary, Alberta, T1Y 6J4, Canada

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Calgary, Alberta, T2N 2T9, Canada

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Calgary, Alberta, T2V 1P9, Canada

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Edmonton, Alberta, T5H 3V9, Canada

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Edmonton, Alberta, T6G 2B7, Canada

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New Westminster, British Columbia, V3L 3W4, Canada

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Vancouver, British Columbia, V5Z 1C6, Canada

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Vancouver, British Columbia, V6Z 1Y6, Canada

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Victoria, British Columbia, V8R 1J8, Canada

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Victoria, British Columbia, V8Z 6R5, Canada

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Winnipeg, Manitoba, R2H 2A6, Canada

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Winnipeg, Manitoba, R3J 3M7, Canada

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Saint John, New Brunswick, E2M 3W5, Canada

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Halifax, Nova Scotia, B3H 3A7, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Ottawa, Ontario, K1Y 4E9, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Toronto, Ontario, M5B 1W8, Canada

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Toronto, Ontario, M5G 2N2, Canada

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Toronto, Ontario, M5T 2S8, Canada

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Chicoutimi, Quebec, G7H 5H6, Canada

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Greenfield Park, Quebec, J4V 2H1, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Montreal, Quebec, H2W 1T8, Canada

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Montreal, Quebec, H2X 3J4, Canada

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Montreal, Quebec, H3A 1A1, Canada

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Montreal, Quebec, H4J 1C5, Canada

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Sainte-Foy, Quebec, G1V 4G2, Canada

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Sherbrooke, Quebec, J1H 5N4, Canada

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Saskatoon, Saskatchewan, S7N 0W8, Canada

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Santiago, Región Metro de Santiago, 8380456, Chile

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Santiago, Región Metro de Santiago, Chile

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Brno, 662 50, Czechia

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Ostrava - Poruba, 708 52, Czechia

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Pilsen, 304 60, Czechia

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Prague, 100 34, Czechia

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Prague, 150 06, Czechia

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Tallinn, 11312, Estonia

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Tallinn, 13419, Estonia

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Tartu, 51014, Estonia

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Helsinki, 00029, Finland

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Joensuu, 80210, Finland

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Jyväskylä, 40620, Finland

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Kuopio, 70210, Finland

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Lappeenranta, 53130, Finland

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Mikkeli, 50100, Finland

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Oulu, 90029, Finland

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Seinäjoki, 60220, Finland

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Tampere, 33520, Finland

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Angers, 49000, France

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Argenteuil, 95107, France

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Bourg-en-Bresse, 01012, France

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Caen, 14000, France

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Créteil, 94010, France

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Le Chesnay, 78157, France

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Lille, 59037, France

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Limoges, 87042, France

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Lyon, 69433, France

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Marseille, 13274, France

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Marseille, 13915, France

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Montauban, 82000, France

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Montpellier, 34295, France

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Nîmes, 30000, France

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Paris, 75012, France

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Paris, 75018, France

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Paris, 75475, France

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Paris, 75674, France

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Paris, 75679, France

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Saint-Michel, 16470, France

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Heidelberg, Baden-Wurttemberg, 69126, Germany

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Mannheim, Baden-Wurttemberg, 68167, Germany

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Augsburg, Bavaria, 86156, Germany

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Erlangen, Bavaria, 91054, Germany

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Munich, Bavaria, 80804, Germany

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Munich, Bavaria, 81545, Germany

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Nuremberg, Bavaria, 90340, Germany

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Frankfurt am Main, Hesse, 60590, Germany

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Giessen, Hesse, 35392, Germany

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Marburg, Hesse, 35043, Germany

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Göttingen, Lower Saxony, 37075, Germany

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Hanover, Lower Saxony, 30625, Germany

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Hanover, Lower Saxony, 30659, Germany

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Greifswald, Mecklenburg-Vorpommern, 17487, Germany

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Neubrandenburg, Mecklenburg-Vorpommern, 17036, Germany

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Rostock, Mecklenburg-Vorpommern, 18057, Germany

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Schwerin, Mecklenburg-Vorpommern, 19055, Germany

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Wismar, Mecklenburg-Vorpommern, 23966, Germany

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Bielefeld, North Rhine-Westphalia, 33617, Germany

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Bonn, North Rhine-Westphalia, 53111, Germany

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Bonn, North Rhine-Westphalia, 53127, Germany

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Cologne, North Rhine-Westphalia, 51109, Germany

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Wuppertal, North Rhine-Westphalia, 42283, Germany

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Ludwigshafen am Rhein, Rhineland-Palatinate, 67063, Germany

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Mainz, Rhineland-Palatinate, 55131, Germany

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Homburg, Saarland, 66421, Germany

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Dresden, Saxony, 01307, Germany

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Leipzig, Saxony, 04103, Germany

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Halle, Saxony-Anhalt, 06120, Germany

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Kiel, Schleswig-Holstein, 24105, Germany

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Lübeck, Schleswig-Holstein, 23538, Germany

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Bad Berka, Thuringia, 99437, Germany

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Erfurt, Thuringia, 99089, Germany

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Jena, Thuringia, 07747, Germany

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Berlin, 10117, Germany

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Berlin, 10249, Germany

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Berlin, 10967, Germany

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Berlin, 12351, Germany

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Berlin, 12683, Germany

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Berlin, 13353, Germany

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Berlin, 13585, Germany

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Berlin, 14050, Germany

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Bremen, 28325, Germany

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Hamburg, 21075, Germany

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Athens, 10676, Greece

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Athens, 11526, Greece

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Athens, 11527, Greece

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Haidari, 124 61, Greece

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Kifissia, 14561, Greece

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Rio, Patras, 265 00, Greece

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Thessaloniki, 54636, Greece

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Thessaloniki, 564 29, Greece

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Thessaloniki, 570 10, Greece

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Kowloon, Hong Kong

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Pokfulam, Hong Kong

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Shatin, Hong Kong

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Tuen Mun, New Territories, Hong Kong

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Budapest, 1124, Hungary

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Bangalore, 560034, India

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Chennai, 600016, India

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GSK Investigational Site

Mangalore, 575 001, India

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Mumbai, 400012, India

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Pune, 411 001, India

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GSK Investigational Site

Pune, 411 011, India

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Afula, 18101, Israel

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Beersheba, Israel

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Haifa, 31048, Israel

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Kfar Saba, 44281, Israel

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Zrifin, 70300, Israel

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Riga, LV 1001, Latvia

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Riga, LV 1002, Latvia

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Riga, LV1079, Latvia

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Kuala Lumpur, 59100, Malaysia

Location

GSK Investigational Site

Kubang Kerian, 16150, Malaysia

Location

GSK Investigational Site

's-Hertogenbosch, 5211 RW, Netherlands

Location

GSK Investigational Site

Amsterdam, 1081 HV, Netherlands

Location

GSK Investigational Site

Apeldoorn, 7334 DZ, Netherlands

Location

GSK Investigational Site

Ede, 6716 RP, Netherlands

Location

GSK Investigational Site

Leeuwarden, 8934 AD, Netherlands

Location

GSK Investigational Site

Rotterdam, 3015 GD, Netherlands

Location

GSK Investigational Site

Utrecht, 3584 CX, Netherlands

Location

GSK Investigational Site

Auckland, 1001, New Zealand

Location

GSK Investigational Site

Auckland, 1701, New Zealand

Location

GSK Investigational Site

Christchurch, 8001, New Zealand

Location

GSK Investigational Site

Tauranga, 3001, New Zealand

Location

GSK Investigational Site

Almada, 2800-950, Portugal

Location

GSK Investigational Site

Amadora, 2720-276, Portugal

Location

GSK Investigational Site

Lisbon, 1169-050, Portugal

Location

GSK Investigational Site

Lisbon, 1649-035, Portugal

Location

GSK Investigational Site

Lisbon, 1769-001, Portugal

Location

GSK Investigational Site

Lisbon, 1849-017, Portugal

Location

GSK Investigational Site

San Juan, 00921, Puerto Rico

Location

GSK Investigational Site

Bucharest, 022328, Romania

Location

GSK Investigational Site

Bucharest, 050098, Romania

Location

GSK Investigational Site

Bucharest, 14461, Romania

Location

GSK Investigational Site

Bucharest, Romania

Location

GSK Investigational Site

Iași, Romania

Location

GSK Investigational Site

Barnaul, 656 045, Russia

Location

GSK Investigational Site

Krasnodar, 350042, Russia

Location

GSK Investigational Site

Moscow, 105203, Russia

Location

GSK Investigational Site

Moscow, 111538, Russia

Location

GSK Investigational Site

Moscow, 115446, Russia

Location

GSK Investigational Site

Moscow, 117049, Russia

Location

GSK Investigational Site

Moscow, 121552, Russia

Location

GSK Investigational Site

Moscow, 125101, Russia

Location

GSK Investigational Site

Perm, 614107, Russia

Location

GSK Investigational Site

Perm, 614990, Russia

Location

GSK Investigational Site

Saint Petersburgh, 192242, Russia

Location

GSK Investigational Site

Smolensk, 214018, Russia

Location

GSK Investigational Site

Tomsk, 634 050, Russia

Location

GSK Investigational Site

Yekaterinburg, 620109, Russia

Location

GSK Investigational Site

Celje, 3000, Slovenia

Location

GSK Investigational Site

Ljubljana, 1000, Slovenia

Location

GSK Investigational Site

Maribor, 2000, Slovenia

Location

GSK Investigational Site

Novo Mesto, 8000, Slovenia

Location

GSK Investigational Site

Slovenj Gradec, 2380, Slovenia

Location

GSK Investigational Site

Šempeter Pri Novi Gorici, Slovenia

Location

GSK Investigational Site

Johannesburg, Gauteng, 2193, South Africa

Location

GSK Investigational Site

Auckland Park, Johannesburg, 2006, South Africa

Location

GSK Investigational Site

Bloemfontein, 9300, South Africa

Location

GSK Investigational Site

Cape Town, 7925, South Africa

Location

GSK Investigational Site

George, 6529, South Africa

Location

GSK Investigational Site

PO Medunsa, 0204, South Africa

Location

GSK Investigational Site

Seoul, 135-710, South Korea

Location

GSK Investigational Site

Seoul, 138-736, South Korea

Location

GSK Investigational Site

Seoul, 152-703, South Korea

Location

GSK Investigational Site

A Coruña, 15006, Spain

Location

GSK Investigational Site

Badalona, 08916, Spain

Location

GSK Investigational Site

Barcelona, 08035, Spain

Location

GSK Investigational Site

Getafe, 28905, Spain

Location

GSK Investigational Site

Madrid, 28041, Spain

Location

GSK Investigational Site

Madrid, 28046, Spain

Location

GSK Investigational Site

Palma de Mallorca, 07014, Spain

Location

GSK Investigational Site

Seville, 41013, Spain

Location

GSK Investigational Site

Seville, 41014, Spain

Location

GSK Investigational Site

Tarrasa, Spain

Location

GSK Investigational Site

Terrassa, 08227, Spain

Location

GSK Investigational Site

Valencia, 46009, Spain

Location

GSK Investigational Site

Gothenburg, SE-416 85, Sweden

Location

GSK Investigational Site

Lund, SE-221 85, Sweden

Location

GSK Investigational Site

Stockholm, SE-141 86, Sweden

Location

GSK Investigational Site

Kaohsiung City, 813, Taiwan

Location

GSK Investigational Site

Taichung, 404, Taiwan

Location

GSK Investigational Site

Taipei, 100, Taiwan

Location

GSK Investigational Site

Tau-Yuan County, Taiwan

Location

GSK Investigational Site

Bangkok, 10330, Thailand

Location

GSK Investigational Site

Bangkok, 10700, Thailand

Location

GSK Investigational Site

Chiang Mai, 50200, Thailand

Location

GSK Investigational Site

Aberdeen, Aberdeenshire, AB25 2ZD, United Kingdom

Location

GSK Investigational Site

Reading, Berkshire, RG1 7AN, United Kingdom

Location

GSK Investigational Site

Glasgow, Lanarkshire, G11 6NT, United Kingdom

Location

GSK Investigational Site

Glasgow, Lanarkshire, G42 9TY, United Kingdom

Location

GSK Investigational Site

Glasgow, Lanarkshire, G51 4TF, United Kingdom

Location

GSK Investigational Site

Wigan, Lancashire, WN6 9EP, United Kingdom

Location

GSK Investigational Site

Liverpool, Merseyside, L7 8XP, United Kingdom

Location

GSK Investigational Site

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

GSK Investigational Site

Bath, Somerset, BA1 3NG, United Kingdom

Location

GSK Investigational Site

Livingston, West Lothian, EH54 6PP, United Kingdom

Location

GSK Investigational Site

Leeds, LS1 3EX, United Kingdom

Location

GSK Investigational Site

Leeds, LS9 7TF, United Kingdom

Location

GSK Investigational Site

Sheffield, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2004
• First Posted: August 23, 2004
• Study Start: September 1, 2004
• Primary Completion: April 1, 2007
• Study Completion: April 15, 2007
• Last Updated: August 21, 2017
• Results First Posted: May 4, 2017

Record last verified: 2017-07

Locations

BR (3); ES (12); RO (5); KR (3); NL (7); GR (9); PR (1); CL (2); LA (3); FI (9); SE (3); TW (4); IN (6); MY (2); FR (20); IL (5); BE (9); CA (30); ZA (6); AU (4); DE (44); GB (13); TH (3); HU (1); PT (6); RU (14); NZ (4); CZ (5); AR (7); HK (4); SL (6); US (132)