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

May 30, 2012 updated by: Romark Laboratories L.C.

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33607
        • Romark Laboratories, L.C.
      • Zephyrhills, Florida, United States, 33542
        • Florida Medical Clinic, P.A.
    • Georgia
      • Marietta, Georgia, United States, 30067
        • Atlanta Gastroenterology
      • Woodstock, Georgia, United States, 30189
        • Atlanta Gastroenterology
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Gasteroenterology Associates
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
        • Minnesota Gastroenterology, P.A., Clinical Research Division
    • New York
      • Great Neck, New York, United States, 11021
        • Long Island Clinical Research Associates, LLP
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Greater Cincinnati Gastroenterology Associates
      • Mayfield Heights, Ohio, United States, 44124
        • Digestive Research & Infusion Institute
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma Foundation for Digestive Research
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Memphis Gastroenterology Group
      • Kingsport, Tennessee, United States, 37660
        • Gastrointestinal Associates, LLC
      • Nashville, Tennessee, United States, 37205
        • Nashville Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
One nitazoxanide 500 mg tablet twice daily for 28 days
Drug: Nitazoxanide
One nitazoxanide 500 mg tablet twice daily for 28 days
Other Names:
  • Alinia
PLACEBO_COMPARATOR: 2
One placebo tablet twice daily for 28 days
Other: Placebo
One placebo tablet twice daily for 28 days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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
Time Frame: Days 14 and 28
Days 14 and 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Romark Laboratories L.C.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (ACTUAL)

December 1, 2007

Study Completion (ACTUAL)

July 1, 2008

Study Registration Dates

First Submitted

August 12, 2005

First Submitted That Met QC Criteria

August 12, 2005

First Posted (ESTIMATE)

August 15, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

May 31, 2012

Last Update Submitted That Met QC Criteria

May 30, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RM01-2018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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