Back to resultsStudy of Nitazoxanide Tablets in the Treatment of Mild to Moderate Active Crohn's Disease
Primary Purpose
Crohn's Disease
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nitazoxanide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease
Eligibility 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.
Sites / Locations
- Romark Laboratories, L.C.
- Florida medical Clinic, P.A.
- Atlanta Gastroenterology
- Atlanta Gastroenterology
- Gasteroenterology Associates
- Minnesota Gastroenterology, P.A., Clinical Research Division
- Long Island Clinical Research Associates, LLP
- Greater Cincinnati Gastroenterology Associates
- Digestive Research & Infusion Institute
- Oklahoma Foundation for Digestive Research
- Memphis Gastroenterology Group
- Gastrointestinal Associates, LLC
- Nashville Medical Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
One nitazoxanide 500 mg tablet twice daily for 28 days
One placebo tablet twice daily for 28 days
Outcomes
Primary Outcome Measures
Change in Crohn's Disease Activity Index (CDAI)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00130390
Brief Title
Study of Nitazoxanide Tablets in the Treatment of Mild to Moderate Active Crohn's Disease
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 Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Terminated
Why Stopped
terminated due to slow recruitment
Study Start Date
August 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Romark Laboratories L.C.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
One nitazoxanide 500 mg tablet twice daily for 28 days
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
One placebo tablet twice daily for 28 days
Intervention Type
Drug
Intervention Name(s)
Nitazoxanide
Other Intervention Name(s)
Alinia
Intervention Description
One nitazoxanide 500 mg tablet twice daily for 28 days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
One placebo tablet twice daily for 28 days
Primary Outcome Measure Information:
Title
Change in Crohn's Disease Activity Index (CDAI)
Time Frame
Day 14
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Carrion, MD
Organizational Affiliation
Romark Laboratories L.C.
Official's Role
Study Director
Facility Information:
Facility Name
Romark Laboratories, L.C.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Florida medical Clinic, P.A.
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Atlanta Gastroenterology
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30067
Country
United States
Facility Name
Atlanta Gastroenterology
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
Gasteroenterology Associates
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Minnesota Gastroenterology, P.A., Clinical Research Division
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Facility Name
Long Island Clinical Research Associates, LLP
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Greater Cincinnati Gastroenterology Associates
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Digestive Research & Infusion Institute
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Oklahoma Foundation for Digestive Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Memphis Gastroenterology Group
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Gastrointestinal Associates, LLC
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Nashville Medical Research
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
12. IPD Sharing Statement
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Study of Nitazoxanide Tablets in the Treatment of Mild to Moderate Active Crohn's Disease
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