A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea

Genzyme

Status and phase: Completed; Phase 2

Conditions: Antibiotic-associated Colitis; Clostridium Difficile-Associated Diarrhea; Clostridium Difficile Diarrhea; Clostridium Enterocolitis; Antibiotic-associated Diarrhea

Treatments: Drug: GT160-246

Study type: Interventional

Funder types: Industry

Identifiers

NCT00034294

GT1105

GTC-80-203

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Be at least 18 years old.
• Have active mild to moderate C. difficile- Associated Diarrhea (CDAD).
• Be able to tolerate oral medication.
• Not be pregnant or breast-feeding.
• Sign and date an informed consent form.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind