An Efficacy and Safety Evaluation of Inflabloc Cap in the Treatment of Patients With Crohn's Disease
- Conditions
- Crohn's Disease
- Registration Number
- NCT00106314
- Lead Sponsor
- Inflabloc Pharmaceuticals
- Brief Summary
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.
- Detailed Description
This is a randomized, double-blind, multi-center, dose response, efficacy and safety study of Inflabloc Cap in patients with moderately active Crohn's disease. The primary objectives of the study are to evaluate the efficacy and safety of Inflabloc Cap in the treatment of patients with moderately active Crohn's disease who also have elevated CRP.
The study will be conducted at approximately 20 centers. Each patient will undergo screening followed by 8 weeks of treatment with Inflabloc Cap. Eligible male and female patients will be randomized in a 1:1:1 ratio to placebo, 30 mg, or 60 mg of DHEA administered twice daily via Inflabloc Cap so that approximately 60 patients complete the study. Following the Screening evaluations, consenting patients will self-administer 2 doses/day of study medication (placebo, 30 mg, or 60 mg of DHEA via Inflabloc Cap) for a total of 8 weeks (approximately 56 days). Patients will be required to complete a daily diary containing evaluations for number of liquid and soft stools, abdominal pain, fever and general well-being. Patients will also record use of study drug, concomitant medications and adverse events on the daily diary. Patients will be required to visit the study center at Screening, Baseline and at Weeks 1, 2, 4 and 8 following the initiation of treatment to turn in their diaries and any unused study medication, receive a physical exam and submit blood samples for chemistry, hematology and specialty laboratory measurements, and a urine sample for urinalysis. A stool sample is also required at Screening for culture and assay for C. difficile toxin. In addition, at the 8-week visit, patients will receive an exit exam including a physical exam (with ECG and vitals) and submit blood samples for chemistry, hematology and specialty laboratory measurements and a urine sample for urinalysis.
The primary efficacy endpoint for this study is defined as achieving a CDAI of 150 or less after 8 weeks of treatment. Secondary and exploratory efficacy endpoints at Weeks 4 and 8 will include achieving a CDAI of 150 or less (at 4 weeks), a change in CDAI from baseline of at least 100 points, a change from baseline in CRP, change from baseline in diarrhea and abdominal pain sub-scores, and change from baseline in IBDQ. Additionally, the safety of Inflabloc Cap when administered to patients with moderately active Crohn's disease with elevated CRP will be monitored through clinical evaluation, clinical laboratory data, collection of Adverse Events and other relevant safety evaluations.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Achieving CDAI (Crohn's Disease Activity Index) of 150 or less after 8 weeks of treatment
- Secondary Outcome Measures
Name Time Method Achieving a CDAI score of 150 or less at 4 weeks Change in CDAI from baseline of at least 100 points at 4 and 8 weeks Change in CRP (C-Reactive Protein) from baseline at 4 and 8 weeks Change in health-related quality of life from baseline at 8 weeks as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) Change from baseline in diarrhea and abdominal pain sub-scores from CDAI
Trial Locations
- Locations (38)
Northwest Gastroenterologists
🇺🇸Arlington Heights, Illinois, United States
Gastrointestinal Research Institute
🇨🇦Vancouver, British Columbia, Canada
IBD Clinical and Research Centre
🇨🇦Winnipeg, New Brunswick, Canada
Atlanta Gastroenterology Associates
🇺🇸Atlanta, Georgia, United States
The University of Chicago Hospital
🇺🇸Chicago, Illinois, United States
The Cleveland Clinic Foundation, Dept. of Gastroenterology
🇺🇸Cleveland, Ohio, United States
Allegheny Center for Digestive Health
🇺🇸Pittsburgh, Pennsylvania, United States
Atilla Ertan, MD
🇺🇸Houston, Texas, United States
University of Washington Medical Center, Department of Gastroenterology
🇺🇸Seattle, Washington, United States
GILDR Group
🇨🇦Edmonton, Alberta, Canada
The Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Philip Hassard, MD
🇨🇦Ottawa, Ontario, Canada
AGA Clinical Research Associates
🇺🇸Egg Harbor Township, New Jersey, United States
Jason Bodzin, MD
🇺🇸Farmington Hills, Michigan, United States
Advanced Clinical Research Institute
🇺🇸Anaheim, California, United States
Clinical Research Associates
🇺🇸Huntsville, Alabama, United States
Maryland Clinical Trials
🇺🇸Severna Park, Maryland, United States
Clinical Research of West Florida
🇺🇸Clearwater, Florida, United States
Credit Valley Digestive Disease Group
🇨🇦Mississauga, Ontario, Canada
New York Center for Clinical Research
🇺🇸Lake Success, New York, United States
Tacoma Digestive Disease Research Center
🇺🇸Tacoma, Washington, United States
University of Vermont College of Medicine / Fletcher Allen Health Care
🇺🇸Burlington, Vermont, United States
Doug Hemphill, MD
🇨🇦Barrie, Ontario, Canada
Saskatoon Medical Specialists
🇨🇦Saskatoon, Saskatchewan, Canada
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Sharp Rees-Stealy Medical Group
🇺🇸San Diego, California, United States
Consultants for Clinical Research
🇺🇸Cincinnati, Ohio, United States
Nashville Medical Research Institute
🇺🇸Nashville, Tennessee, United States
SMG Reseach
🇺🇸Salt Lake City, Utah, United States
Wisconsin Center for Advanced Research
🇺🇸Milwaukee, Wisconsin, United States
University of Louisville, Department of Internal Medicine
🇺🇸Louisville, Kentucky, United States
Borland-Groover Clinic
🇺🇸Jacksonville, Florida, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Charlotte Gastroenterology and Hepatology
🇺🇸Charlotte, North Carolina, United States
McGuire DVAMC GI (111N)
🇺🇸Richmond, Virginia, United States
Mountain West Gastroenterology
🇺🇸Salt Lake City, Utah, United States
Alan Cockeram, MD
🇨🇦Saint John, New Brunswick, Canada
Queen Elizabeth II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada