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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00130390
Recruitment Status : Terminated (terminated due to slow recruitment)
First Posted : August 15, 2005
Last Update Posted : May 31, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Drug: Nitazoxanide Other: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : August 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

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 Name: Alinia

Placebo Comparator: 2
One placebo tablet twice daily for 28 days
Other: Placebo
One placebo tablet twice daily for 28 days

Primary Outcome Measures :
  1. Change in Crohn's Disease Activity Index (CDAI) [ Time Frame: Day 14 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00130390

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United States, Florida
Romark Laboratories, L.C.
Tampa, Florida, United States, 33607
Florida medical Clinic, P.A.
Zephyrhills, Florida, United States, 33542
United States, Georgia
Atlanta Gastroenterology
Marietta, Georgia, United States, 30067
Atlanta Gastroenterology
Woodstock, Georgia, United States, 30189
United States, Louisiana
Gasteroenterology Associates
Baton Rouge, Louisiana, United States, 70809
United States, Minnesota
Minnesota Gastroenterology, P.A., Clinical Research Division
Plymouth, Minnesota, United States, 55446
United States, New York
Long Island Clinical Research Associates, LLP
Great Neck, New York, United States, 11021
United States, Ohio
Greater Cincinnati Gastroenterology Associates
Cincinnati, Ohio, United States, 45219
Digestive Research & Infusion Institute
Mayfield Heights, Ohio, United States, 44124
United States, Oklahoma
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Memphis Gastroenterology Group
Germantown, Tennessee, United States, 38138
Gastrointestinal Associates, LLC
Kingsport, Tennessee, United States, 37660
Nashville Medical Research
Nashville, Tennessee, United States, 37205
Sponsors and Collaborators
Romark Laboratories L.C.
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Study Director: Maria Carrion, MD Romark Laboratories L.C.
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Responsible Party: Romark Laboratories L.C. Identifier: NCT00130390    
Other Study ID Numbers: RM01-2018
First Posted: August 15, 2005    Key Record Dates
Last Update Posted: May 31, 2012
Last Verified: May 2012
Keywords provided by Romark Laboratories L.C.:
Crohn's Disease
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Antiparasitic Agents
Anti-Infective Agents