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

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00130390
• Other study ID #: RM01-2018
• Status: Terminated
• Phase: Phase 2
• First received: August 12, 2005
• Last updated: May 30, 2012
• Start date: August 2005
• Est. completion date: July 2008

Study information

• Verified date: May 2012
• Source: Romark Laboratories L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 98
• Est. completion date: July 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

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

Other:
• Placebo
One placebo tablet twice daily for 28 days

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Romark Laboratories L.C.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Crohn's Disease Activity Index (CDAI)		Day 14	No
Secondary	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	No