NCT00384527

Study of Nitazoxanide in the Treatment of Clostridium Difficile-associated Disease

Multicenter, Double-blind Study of Nitazoxanide Compared to Vancomycin in the Treatment of Clostridium Difficile-associated Disease

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Romark Laboratories L.C. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Clostridium Infections

Interventions

Type	Name	Description
DRUG	Nitazoxanide	One nitazoxanide 500 mg tablet twice daily plus one vancomycin-placebo capsule four times daily for 10 days.
DRUG	Vancomycin	One vancomycin 125 mg capsule four times daily plus one nitazoxanide-placebo twice daily for 10 days.

Timeline

• Start date: 2006-12-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2006-10-06
• Last updated: 2015-05-05

Locations

10 sites across 1 country: United States