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

This study has been terminated.
(terminated due to slow recruitment)
Sponsor:
Information provided by (Responsible Party):
Romark Laboratories L.C.
ClinicalTrials.gov Identifier:
NCT00130390
First received: August 12, 2005
Last updated: May 30, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Crohn's Disease
Drug: Nitazoxanide
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Romark Laboratories L.C.:

Primary Outcome Measures:
  • Change in Crohn's Disease Activity Index (CDAI) [ Time Frame: Day 14 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Enrollment: 98
Study Start Date: August 2005
Study Completion Date: July 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130390

Locations
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.
Investigators
Study Director: Maria Carrion, MD Romark Laboratories L.C.
  More Information

No publications provided

Responsible Party: Romark Laboratories L.C.
ClinicalTrials.gov Identifier: NCT00130390     History of Changes
Other Study ID Numbers: RM01-2018
Study First Received: August 12, 2005
Last Updated: May 30, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Romark Laboratories L.C.:
Crohn's Disease

Additional relevant MeSH terms:
Crohn Disease
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Nitazoxanide
Anti-Infective Agents
Antiparasitic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014