Overview

Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis

Status:
Completed
Trial end date:
2005-09-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Romark Laboratories L.C.
Treatments:
Metronidazole
Nitazoxanide