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

Phase 3CompletedNCT00196794

Genzyme, a Sanofi Company520 enrolled

Overview

Approximately 520 patients will be entered into this study taking place throughout Australia and Europe. 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. The total length of participation is approximately 6 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

520

Conditions

Clostridium Enterocolitis Diarrhea

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 years of age and above * The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea * Less than or equal to 48 hours of treatment with metronidazole, vancomycin or other antibacterial therapy specific for CDAD * Baseline serum potassium \> 3.0 mmol (meq)/L * Patient considered sufficiently stable clinically to likely complete 6 week study period.

Locations (138)

Unnamed facility

Adelaide, Australia

Unnamed facility

Bedford Park, Australia

Unnamed facility

Cairns, Australia

Unnamed facility

Concord, Australia

Unnamed facility

Darlinghurst, Australia

Unnamed facility

Five Dock, Australia

Outcomes

Primary Outcomes

Resolution of diarrhea

Secondary Outcomes

Time to resolution of diarrhea

Recurrence rate

Number of stools

Average stool consistency

Treatment success