Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clostridium Difficile

Clinical Trial Details

NCT number	NCT00417872
Study type	Interventional
Source	Romark Laboratories L.C.
Contact
Status	Completed
Phase	Phase 2
Start date	January 2004
Completion date	September 2005

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