Trials / Completed
CompletedNCT00034294
A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea
A Randomized, Double-Blind Study of GT160-246 Versus Vancomycin in Patients With C. Difficile-Associated Diarrhea
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 300 (planned)
- Sponsor
- Genzyme, a Sanofi Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Approximately 300 patients will be entered into this study taking place throughout the United States, Canada and the United Kingdom. This study aims to determine if an investigational drug is safe and effective for treating the symptoms of C. difficile-associated diarrhea and lowering the risk of repeat episodes of diarrhea. 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 10 weeks.
Conditions
- Clostridium Difficile-Associated Diarrhea
- Clostridium Enterocolitis
- Clostridium Difficile Diarrhea
- Antibiotic-associated Colitis
- Antibiotic-associated Diarrhea
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GT160-246 |
Timeline
- Start date
- 2002-02-01
- Completion
- 2003-07-01
- First posted
- 2002-04-25
- Last updated
- 2015-03-05
Locations
99 sites across 4 countries: United States, Canada, Puerto Rico, United Kingdom
Source: ClinicalTrials.gov record NCT00034294. Inclusion in this directory is not an endorsement.