NCT00417872

Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis

Multicenter, Double Blind, Metronidazole Controlled, Dose Range Finding Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 114 (planned)
• Sponsor: Romark Laboratories L.C. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to demonstrate non-inferiority of nitazoxanide administered 500 mg b.i.d compared to metronidazole administered 250 mg q.i.d. in resolving symptoms of Clotridium difficile colitis after seven days of treatment. Secondary objectives are to provide information on the times from first dose to last unformed stool and resolution of symptoms of colitis, the sustained response rates for the different tratment groups and the effect of treatment on Clostridium difficile toxin enzyme immunoassay/culture results during hospitalization.

Conditions

• Clostridium Difficile

Interventions

Type	Name	Description
DRUG	Nitazoxanide
DRUG	Metronidazole

Timeline

• Start date: 2004-01-01
• Completion: 2005-09-01
• First posted: 2007-01-04
• Last updated: 2007-01-04

Locations

7 sites across 1 country: United States