NCT00130390

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

Multi-center, Randomized, Double-Blind, Placebo-Controlled Trial of Nitazoxanide Tablets in the Treatment of Mild to Moderate Active Crohn's Disease in Adults

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Romark Laboratories L.C. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

There is a significant need for a safe and effective treatment of Crohn's disease. It is recognized that bacteria in the gut lumen may have a role in the etiology and/or symptoms of this disease. Antimicrobials have often been used in treating Crohn's disease although their effectiveness has not been well established. Pro-inflammatory cytokines are also believed to play an important role in this disease. Nitazoxanide, a thiazolide anti-infective, is active in vitro against a broad spectrum of anaerobic bacteria, and it inhibits secretion of pro-inflammatory cytokines including IL-2, -4, -5, -6, -8, -10 and TNF alpha. The drug is also highly concentrated in the gastrointestinal tract. With these characteristics, nitazoxanide offers a unique approach to treatment of Crohn's disease.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Nitazoxanide	One nitazoxanide 500 mg tablet twice daily for 28 days
OTHER	Placebo	One placebo tablet twice daily for 28 days

Timeline

• Start date: 2005-08-01
• Primary completion: 2007-12-01
• Completion: 2008-07-01
• First posted: 2005-08-15
• Last updated: 2012-05-31

Locations

13 sites across 1 country: United States