An Efficacy and Safety Evaluation of Inflabloc Cap in the Treatment of Patients With Crohn's Disease

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inflabloc Pharmaceuticals
• Treatments: Dehydroepiandrosterone

Criteria

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.