The primary objective of the study is to demonstrate non-inferiority of nitazoxanide compared to vancomycin in resolving symptoms of Clostridium difficile-associated disease (CDAD)...
Date First Received: October 5, 2006
Last Updated: April 24, 2007
Verified by: Romark Laboratories L.C., April 2007
Clinical Trial Phase: Phase 3 | Start Date: October 2006
Overall Status: Recruiting
Estimated Enrollment: 350
Brief Summary
Official Title: “Multicenter, Double-Blind Study of Nitazoxanide Compared to Vancomycin in the Treatment of Clostridium Difficile-Associated Disease”
Condition Keyword(s):
Intervention(s):
The primary objective of the study is to demonstrate non-inferiority of nitazoxanide compared to vancomycin in resolving symptoms of Clostridium difficile-associated disease (CDAD).
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Nitazoxanide
- Drug: Vancomycin
Outcome Measures for this Clinical Trial
Primary Measures
- Clinical response (resolution of all symptoms of CDAD) at end of treatment.
Secondary Measures
- Time from first dose to resolution of symptoms of CDAD
- Recurrence prior to study day 31
- Sustained clinical response at day 31
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Age ≥ 18 years.
- Patients with new onset of disease evidenced by diarrhea (≥ 3 unformed stools within 24 hours), and one or more of the following symptoms of CDAD:
- abdominal pain or cramps
- peripheral leukocytosis
- fever
- C. difficile toxin A or B detected in a stool specimen obtained within 3 days before enrollment by enzyme immunoassay.
- Patients willing to avoid the following medications during the study:
- oral and intravenous metronidazole
- oral vancomycin
- anti-peristaltic drugs
- opiates (patients on opiates may be included in the study if they were taking opiates prior to enrollment and the dose is not increased during the study)
- Saccharomyces cerevisiae (baker’s yeast)
- Lactobacillus GG
- cholestyramine
- colestipol
Exclusion Criteria:
- Patients with other known causes of diarrhea or colitis (e.g., Shigella, Salmonella, Cryptosporidium parvum, Giardia lamblia, Entamoeba histolytica, inflammatory bowel disease, irritable bowel syndrome, advanced AIDS or chemotherapy for malignancy).
- Patients that commonly have 3 or more stools per day and/or severe abdominal pain in the absence of CDAD.
- Patients with severe lactose intolerance.
- Patients with more than 1 recurrence of CDAD during the 6 months prior to enrollment.
- Patients unable to take oral medications.
- Use within 1 week of enrollment of any drug or therapy with anti-C. difficile activity such as oral or intravenous metronidazole and oral vancomycin. [Patients that have taken up to 3 doses of metronidazole or vancomycin can be included in the study].
- Females of child bearing age who are either pregnant, breast-feeding or not using birth control and are sexually active.
- Patients who are either clinically unstable (e.g., fulminant disease patients with signs of toxic megacolon, imminent perforation, colectomy or death) or unlikely to live throughout the 31-day duration of the study due to underlying illness.
- History of hypersensitivity to nitazoxanide or vancomycin or any active ingredient in the formulations.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Romark Laboratories L.C.
Overall Clinical Trial Officials and Contacts
Carol Kauffman, MD Principal Investigator John D. Dingell VAMC
Overall Contact: Ron Patrizio, B.A. 813-281-3326 ron.patrizio@romark.com
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00384527
Study ID Number: RM01-3032
ClinicalTrials.gov Identifier: NCT00384527
Health Authority: United States: Food and Drug Administration
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