Status:
TERMINATED
Study of Nitazoxanide Tablets in the Treatment of Mild to Moderate Active Crohn's Disease
Lead Sponsor:
Romark Laboratories L.C.
Conditions:
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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. Anti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00130390
Start Date
August 1 2005
End Date
July 1 2008
Last Update
May 31 2012
Active Locations (13)
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1
Romark Laboratories, L.C.
Tampa, Florida, United States, 33607
2
Florida medical Clinic, P.A.
Zephyrhills, Florida, United States, 33542
3
Atlanta Gastroenterology
Marietta, Georgia, United States, 30067
4
Atlanta Gastroenterology
Woodstock, Georgia, United States, 30189