Ulcerative Colitis Clinical Trial
Official title:
A Phase II, Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-ranging Study of Intravenous Daclizumab in Patients With Moderate-to-severe Ulcerative Colitis
Verified date | July 2009 |
Source | Facet Biotech |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of The PROSPECT Study is to evaluate an investigational medication for the treatment of moderate to severe ulcerative colitis. This study is being conducted at up to 38 clinical research centers in the US, Canada, and Belgium, and is open to male and female patients 12 years and older. Participants in the study will have a number of visits to a research center over a five-month period. All study related care and medication is provided to qualified participants at no cost: this includes all visits, examinations, and laboratory work.
Status | Completed |
Enrollment | 150 |
Est. completion date | July 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years and older |
Eligibility |
- Moderate to severe active ulcerative colitis diagnosed for at least 4 months. - Mayo score of 5-10 (inclusive) - Not used any investigational therapy for 30 days prior to screening - No treatment with monoclonal antibody therapy within 12 weeks of screening - No prior treatment with daclizumab |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | Universitair Ziekenhuis Gasthuisberg | Leuven | |
Canada | University of Alberta | Edmonton | Alberta |
Canada | London Health Science Center | London | Ontario |
Canada | Montreal General Hospital | Montreal | Quebec |
Canada | Vancouver General Hospital | Vancouver | British Columbia |
United States | Advanced Medical Research Institute | Anaheim | California |
United States | Medlantic Investigators Network | Annapolis | Maryland |
United States | Atlanta Gastroenterology Associates | Atlanta | Georgia |
United States | University of North Carolina | Chapel Hill | North Carolina |
United States | The University of Chicago Hospital | Chicago | Illinois |
United States | Consultants for Clinical Research | Cincinnati | Ohio |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | Columbia Gastro Associates | Columbia | South Carolina |
United States | GVAMC | Gainesville | Florida |
United States | Long Island Clinical Research Associates | Great Neck | New York |
United States | Clinical Research Associates | Hollywood | Florida |
United States | Clinical Research Associates | Huntsville | Alabama |
United States | Physician Office | Jacksonville | Florida |
United States | New York Center for Clinical Research | Lake Success | New York |
United States | University of Kentucky Chandler Medical Center | Lexington | Kentucky |
United States | Cedar Sinai Medical Center | Los Angeles | California |
United States | Research Foundation of America | Los Angeles | California |
United States | Western Gastroenterology Group | Los Angeles | California |
United States | Memphis Gastroenterology Group, P.C. | Memphis | Tennessee |
United States | Drug Research Services, Inc. | Metairie | Louisiana |
United States | Wisconsin Center for Advanced Research | Milwaukee | Wisconsin |
United States | Nashville Medical Research | Nashville | Tennessee |
United States | Digestive and Liver Disease Specialists | Norfolk | Virginia |
United States | Mount Sinai Medical Center | North Miami Beach | Florida |
United States | Oklahoma Foundation for Digestive Research | Oklahoma City | Oklahoma |
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
United States | McGuire DVAMC | Richmond | Virginia |
United States | Richmond GI Research Group | Richmond | Virginia |
United States | Fletcher Allen Health Care | S. Burlington | Vermont |
United States | St. Louis Center for Clinical Research | St. Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Facet Biotech |
United States, Belgium, Canada,
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