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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT00130390

Run by

Romark Laboratories L.C.

People needed

98

Starts

2005-08-01

Expected to finish

2008-07-01

Last updated by the study team

2012-05-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Romark Laboratories, L.C. — Tampa, Florida, United States
• Florida medical Clinic, P.A. — Zephyrhills, Florida, United States
• Atlanta Gastroenterology — Marietta, Georgia, United States
• Atlanta Gastroenterology — Woodstock, Georgia, United States
• Gasteroenterology Associates — Baton Rouge, Louisiana, United States
• Minnesota Gastroenterology, P.A., Clinical Research Division — Plymouth, Minnesota, United States
• Long Island Clinical Research Associates, LLP — Great Neck, New York, United States
• Greater Cincinnati Gastroenterology Associates — Cincinnati, Ohio, United States
• Digestive Research & Infusion Institute — Mayfield Heights, Ohio, United States
• Oklahoma Foundation for Digestive Research — Oklahoma City, Oklahoma, United States
• Memphis Gastroenterology Group — Germantown, Tennessee, United States
• Gastrointestinal Associates, LLC — Kingsport, Tennessee, United States
• Nashville Medical Research — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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