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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
334
Alliance Clinical Research
Birmingham, Alabama, United States
Clinical Research Advantage, Inc. / Warner Family Practice, PC
Chandler, Arizona, United States
Connect Clinical Research Center
Chandler, Arizona, United States
Clinical Research Advantage, Inc. / Central Phoenix Medical Clinic, LLC
Phoenix, Arizona, United States
Arizona Research Center
Phoenix, Arizona, United States
The proportion of subjects with improved bowel movement frequency
Time frame: 12 weeks
Stool frequency
Time frame: 12 weeks
Daily average ratings of stool consistency
Time frame: 12 weeks
Instances of rescue medicine usage
Time frame: 12 weeks
Onset time to CSBM
Time frame: 12 weeks
Onset time to SBM
Time frame: 12 weeks
Severity of straining
Time frame: 12 weeks
Abdominal discomfort
Time frame: 12 weeks
Abdominal pain
Time frame: 12 weeks
Bloating
Time frame: 12 weeks
Constipation severity
Time frame: 12 weeks
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