Study of Nitazoxanide Tablets in the Treatment of Mild to Moderate Active Crohn's Disease
- Registration Number
- NCT00130390
- Lead Sponsor
- Romark Laboratories L.C.
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 98
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 2 Placebo One placebo tablet twice daily for 28 days 1 Nitazoxanide One nitazoxanide 500 mg tablet twice daily for 28 days
- Primary Outcome Measures
Name Time Method Change in Crohn's Disease Activity Index (CDAI) Day 14
- Secondary Outcome Measures
Name Time Method Clinical response; remission; change in C-reactive protein; reduction in steroid use; fistula response; change in Perianal Disease Activity Index (PDAI); change in plasma cytokine levels Days 14 and 28
Trial Locations
- Locations (12)
Gastrointestinal Associates, LLC
🇺🇸Kingsport, Tennessee, United States
Nashville Medical Research
🇺🇸Nashville, Tennessee, United States
Romark Laboratories, L.C.
🇺🇸Tampa, Florida, United States
Atlanta Gastroenterology
🇺🇸Woodstock, Georgia, 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
Memphis Gastroenterology Group
🇺🇸Germantown, Tennessee, United States
Gasteroenterology Associates
🇺🇸Baton Rouge, Louisiana, United States
Florida medical Clinic, P.A.
🇺🇸Zephyrhills, Florida, United States
Oklahoma Foundation for Digestive Research
🇺🇸Oklahoma City, Oklahoma, United States