Status:
COMPLETED
An Efficacy and Safety Evaluation of Inflabloc Cap in the Treatment of Patients With Crohn's Disease
Lead Sponsor:
Inflabloc Pharmaceuticals
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
October 1 2006
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00106314
Start Date
January 1 2005
End Date
October 1 2006
Last Update
October 19 2007
Active Locations (38)
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1
Clinical Research Associates
Huntsville, Alabama, United States, 35801
2
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
3
Sharp Rees-Stealy Medical Group
San Diego, California, United States, 92123
4
Clinical Research of West Florida
Clearwater, Florida, United States, 33765