Study of Nitazoxanide Tablets in the Treatment of Mild to Moderate Active Crohn's Disease
NCT ID: NCT00130390
Last Updated: 2012-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
98 participants
INTERVENTIONAL
2005-08-31
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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1
One nitazoxanide 500 mg tablet twice daily for 28 days
Nitazoxanide
One nitazoxanide 500 mg tablet twice daily for 28 days
2
One placebo tablet twice daily for 28 days
Placebo
One placebo tablet twice daily for 28 days
Interventions
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Nitazoxanide
One nitazoxanide 500 mg tablet twice daily for 28 days
Placebo
One placebo tablet twice daily for 28 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Romark Laboratories L.C.
INDUSTRY
Responsible Party
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Principal Investigators
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Maria Carrion, MD
Role: STUDY_DIRECTOR
Romark Laboratories L.C.
Locations
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Romark Laboratories, L.C.
Tampa, Florida, United States
Florida medical Clinic, P.A.
Zephyrhills, Florida, United States
Atlanta Gastroenterology
Marietta, Georgia, United States
Atlanta Gastroenterology
Woodstock, Georgia, United States
Gasteroenterology Associates
Baton Rouge, Louisiana, United States
Minnesota Gastroenterology, P.A., Clinical Research Division
Plymouth, Minnesota, United States
Long Island Clinical Research Associates, LLP
Great Neck, New York, United States
Greater Cincinnati Gastroenterology Associates
Cincinnati, Ohio, United States
Digestive Research & Infusion Institute
Mayfield Heights, Ohio, United States
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States
Memphis Gastroenterology Group
Germantown, Tennessee, United States
Gastrointestinal Associates, LLC
Kingsport, Tennessee, United States
Nashville Medical Research
Nashville, Tennessee, United States
Countries
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Other Identifiers
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RM01-2018
Identifier Type: -
Identifier Source: org_study_id
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