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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2007

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.

Intervention(s) in this Clinical Trial

• Drug: Nitazoxanide
  • One nitazoxanide 500 mg tablet twice daily for 28 days
• Other: Placebo
  • One placebo tablet twice daily for 28 days

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • One nitazoxanide 500 mg tablet twice daily for 28 days
• Placebo Comparator: 2
  • One placebo tablet twice daily for 28 days

Primary Measures

• Change in Crohn's Disease Activity Index (CDAI)
  • Time Frame: Day 14
    Safety Issue?: No

Secondary Measures

• 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
  • Time Frame: Days 14 and 28
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Romark Laboratories L.C.

Overall Clinical Trial Officials and Contacts

Maria Carrion, MD Study Director Romark Laboratories L.C.  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00130390

Study ID Number: RM01-2018

ClinicalTrials.gov Identifier: NCT00130390

Health Authority: United States: Food and Drug Administration