Chronic Idiopathic Constipation Clinical Trial
This will be a multi-center, randomized, double-blind, placebo-controlled study of YKP10811
capsules in patients with chronic idiopathic constipation. Following a 2-week baseline
period, approximately 320 eligible patients with <3 complete spontaneous bowel movements
(CSBM) and ≤ 5 SBMs per week will be randomly assigned equally to receive one of the
following oral treatments; placebo or YKP10811 capsules once daily for 12 weeks followed by
a 2 week follow-up period.
The objectives of this study are:
- To assess the efficacy of YKP10811 once daily at relieving constipation and associated
symptoms in subjects with chronic idiopathic constipation.
- To determine the safety and tolerability of YKP10811 once daily in subjects with
chronic idiopathic constipation.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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