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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Crohn's Disease

Intervention / Treatment
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* Drug: Nitazoxanide
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>One nitazoxanide 500 mg tablet twice daily for 28 days | Drug: Nitazoxanide<br>* One nitazoxanide 500 mg tablet twice daily for 28 days<br>* Other names: Alinia;|
| Placebo Comparator: 2<br>One placebo tablet twice daily for 28 days | Other: Placebo<br>* One placebo tablet twice daily for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Crohn's Disease Activity Index (CDAI) |  | Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's Disease