Study of Nitazoxanide Tablets in the Treatment of Mild to Moderate Active Crohn's Disease

• Status: Terminated
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the efficacy and safety of nitazoxanide compared to a placebo in reducing the signs and symptoms of mild to moderate active Crohn's disease in adults.

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

Details

• Lead Sponsor: Romark Laboratories L.C.
• Treatments: Nitazoxanide

Criteria

Inclusion Criteria:

• Age ≥18 years.

• Diagnosis of Crohn's disease with colonic or perianal involvement confirmed by endoscopic, histologic and/or radiologic data.

• CDAI score ≥200 and ≤400.

Exclusion Criteria:

• Subjects known to have stool positive for Clostridium difficile toxin A or B, bacterial enteric pathogens, rotavirus, Cryptosporidium species (spp.), and/or ova/parasites.

• Evidence of bowel obstruction.

• Females that are pregnant, breast-feeding or not using birth control and are sexually active.

• Serious systemic disorders incompatible with the study.

• History of hypersensitivity to nitazoxanide or any inactive ingredient in the formulation.

• Uncontrolled gastro-intestinal bleeding.

• Evidence of intestinal abscess, non-perianal fistula or stricture.

• Patients who have received antibiotics in the past 7 days.

• Patients receiving >20 mg of prednisone, or its equivalent.

• Patients receiving Anucort-HC or rectal steroids.

• Patients receiving immunosuppressive therapy that has not been stabilized.

• Patients who have received TNF-alpha inhibitor treatments such as infliximab or other biological agents within three months prior to start of treatment.

• Patients with Crohn's disease confined to the esophagus, stomach and small bowel.