A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C.Difficile - Associated Diarrhea

Pseudomembranous Colitis Clinical Trial

Official title:
A Randomized, Double-Blind Study of GT267-004 Versus Vancomycin, and GT267-004 Versus Metronidazole, in Patients With C.Difficile - Associated Diarrhea

Status Completed

Clinical Trial Summary

Approximately 520 patients will be entered into this study taking place throughout the US and Canada. This study aims to determine if an investigational drug is safe and effective for treating symptoms of C. difficile-associated diarrhea (CDAD) and lowering the risk of repeat episodes of CDAD. The investigational drug will be evaluated in comparison to current standard antibiotic treatment, so all patients will receive active medication. All study related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is approximately 6 weeks.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00106509
Study type	Interventional
Source	Sanofi
Contact
Status	Completed
Phase	Phase 3
Start date	March 2005
Completion date	February 2007

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00382304` - A Study of the Absorption of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea	Phase 2
Completed	`NCT00304876` - Fecal Bacterial Flora in Clostridium Difficile-Associated Diarrhea	N/A
Completed	`NCT03427229` - Fecal Microbiota Transplantation for Severe Clostridium Difficile Infection	Phase 2
Completed	`NCT00304369` - Response of Clostridium Difficile Infection to Metronidazole Therapy	N/A
Completed	`NCT00304889` - Vancomycin vs. Nitazoxanide to Treat Recurrent C. Difficile Colitis	Phase 3
Completed	`NCT00304408` - Association Between Response to Treatment of C. Diff Colitis and Anti-C.Diff Toxin Antibody	Phase 4
Completed	`NCT00304356` - Compassionate Use of Nitazoxanide for the Treatment of Clostridium Difficile Infection	Phase 3
Completed	`NCT00182429` - Efficacy of Metronidazole Versus Metronidazole and Rifampin in CDAD Treatment	Phase 3
Withdrawn	`NCT00304863` - Addition of Lactobacillus to Metronidazole in Treatment of CDAD	Phase 4