Crohn's Disease Clinical Trial
Official title:
A Randomized, Double-Blind, Multi-Center, Dose Response, Efficacy and Safety Evaluation of Inflabloc Cap in the Treatment of Patients With Moderately Active Crohn's Disease
Verified date | October 2007 |
Source | Inflabloc Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to evaluate the efficacy and safety of Inflabloc Cap (Dehydroepiandrosterone [DHEA]) in the treatment of patients with moderately active Crohn's disease.
Status | Completed |
Enrollment | 75 |
Est. completion date | October 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of Crohn's disease made at least 3 months prior to study entry. - C-reactive protein above the upper limit of normal. - Currently have moderately active Crohn's disease. Exclusion Criteria: - Women who are pregnant or lactating or of childbearing potential. - History of colostomy, ileostomy, intestinal resection resulting in short bowel syndrome or symptomatic strictures. - Symptoms (abdominal pain, vomiting) and radiographic evidence of mechanical bowel obstruction within the previous 6 months. - Fistulizing disease. - Positive stool culture for enteric pathogens and/or C. difficile toxin. - History of significant disease. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Doug Hemphill, MD | Barrie | Ontario |
Canada | GILDR Group | Edmonton | Alberta |
Canada | Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia |
Canada | Credit Valley Digestive Disease Group | Mississauga | Ontario |
Canada | Philip Hassard, MD | Ottawa | Ontario |
Canada | Alan Cockeram, MD | Saint John | New Brunswick |
Canada | Saskatoon Medical Specialists | Saskatoon | Saskatchewan |
Canada | Gastrointestinal Research Institute | Vancouver | British Columbia |
Canada | IBD Clinical and Research Centre | Winnipeg | New Brunswick |
United States | Advanced Clinical Research Institute | Anaheim | California |
United States | Northwest Gastroenterologists | Arlington Heights | Illinois |
United States | Atlanta Gastroenterology Associates | Atlanta | Georgia |
United States | University of Vermont College of Medicine / Fletcher Allen Health Care | Burlington | Vermont |
United States | The Medical University of South Carolina | Charleston | South Carolina |
United States | Charlotte Gastroenterology and Hepatology | Charlotte | North Carolina |
United States | The University of Chicago Hospital | Chicago | Illinois |
United States | Consultants for Clinical Research | Cincinnati | Ohio |
United States | Clinical Research of West Florida | Clearwater | Florida |
United States | The Cleveland Clinic Foundation, Dept. of Gastroenterology | Cleveland | Ohio |
United States | AGA Clinical Research Associates | Egg Harbor Township | New Jersey |
United States | Jason Bodzin, MD | Farmington Hills | Michigan |
United States | Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania |
United States | Atilla Ertan, MD | Houston | Texas |
United States | Clinical Research Associates | Huntsville | Alabama |
United States | Borland-Groover Clinic | Jacksonville | Florida |
United States | New York Center for Clinical Research | Lake Success | New York |
United States | University of Louisville, Department of Internal Medicine | Louisville | Kentucky |
United States | Wisconsin Center for Advanced Research | Milwaukee | Wisconsin |
United States | Nashville Medical Research Institute | Nashville | Tennessee |
United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
United States | Allegheny Center for Digestive Health | Pittsburgh | Pennsylvania |
United States | McGuire DVAMC GI (111N) | Richmond | Virginia |
United States | Mountain West Gastroenterology | Salt Lake City | Utah |
United States | SMG Reseach | Salt Lake City | Utah |
United States | Sharp Rees-Stealy Medical Group | San Diego | California |
United States | University of Washington Medical Center, Department of Gastroenterology | Seattle | Washington |
United States | Maryland Clinical Trials | Severna Park | Maryland |
United States | Tacoma Digestive Disease Research Center | Tacoma | Washington |
Lead Sponsor | Collaborator |
---|---|
Inflabloc Pharmaceuticals |
United States, Canada,
Andus T, Klebl F, Rogler G, Bregenzer N, Schölmerich J, Straub RH. Patients with refractory Crohn's disease or ulcerative colitis respond to dehydroepiandrosterone: a pilot study. Aliment Pharmacol Ther. 2003 Feb;17(3):409-14. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Achieving CDAI (Crohn's Disease Activity Index) of 150 or less after 8 weeks of treatment | |||
Secondary | Achieving a CDAI score of 150 or less at 4 weeks | |||
Secondary | Change in CDAI from baseline of at least 100 points at 4 and 8 weeks | |||
Secondary | Change in CRP (C-Reactive Protein) from baseline at 4 and 8 weeks | |||
Secondary | Change in health-related quality of life from baseline at 8 weeks as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) | |||
Secondary | Change from baseline in diarrhea and abdominal pain sub-scores from CDAI |
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