Antibiotic-associated Colitis, Antibiotic-associated Diarrhea, Clostridium Difficile-Associated Diarrhea, Clostridium Difficile Diarrhea, Clostridium Enterocolitis
Conditions
Keywords
C. difficile-associated diarrhea, CDAD, Clostridium difficile-Associated Diarrhea, Clostridium enterocolitis, antibiotic-associated diarrhea, clostridium difficile colitis, infectious diarrhea, chronic diarrhea, antibiotic-associated colitis
Brief 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.
Interventions
DRUGGT160-246
Sponsors
Genzyme, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
Canada, Puerto Rico, United Kingdom, United States
Outcome results
None listed