The primary objective of this study is to investigate the safety and efficacy of OPT-80 versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).
This is a multicenter, double-blind, randomized, parallel group study. The subjects who meet all of the inclusion criteria and none of the exclusion criteria will be randomized, and will orally receive either OPT-80 twice daily or vancomycin powder four times daily for 10 days. A follow-up investigation will be performed 28 (±3) days after the completion of study drug administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
210
oral
oral
Unnamed facility
Chugoku, Japan
Unnamed facility
Chūbu, Japan
Unnamed facility
Hokkaido, Japan
Unnamed facility
Kanto, Japan
Unnamed facility
Kinnki, Japan
Global cure rate
Global cure rate is the rate of the subjects satisfying both of the following: being cured at the completion of study drug administration; without recurrence during the follow-up period
Time frame: Up to 38 days
Cure rate
Time frame: Day 10 -11 of the study period
Recurrence rate of CDAD
Time frame: during the 4-week follow-up period, up to Day 38
Time to resolution of diarrhea
Time frame: up to 38 days
Microbiological efficacy
Time frame: Up to 38 days
Plasma concentration of OPT-80(fidaxomicin)
Time frame: Before administration, Day 1 and Day 10-11
Plasma concentration of OP-1118
Time frame: Before administration, Day 1 and Day 10-11
Fecal concentration of OPT-80(fidaxomicin)
Time frame: Day 10-11
Fecal concentration of OP-1118
Time frame: Day 10-11
Safety assessed by the incidence of adverse events, vital signs, ECGs and laboratory tests
Time frame: Up to 38 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Kyushu, Japan
Unnamed facility
Tōhoku, Japan