NCT01989234

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, 12-Week, Dose-Range-Finding Trial of YKP10811 Capsules Administered Once Daily to Subjects With Chronic Idiopathic Constipation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 334 (actual)
• Sponsor: SK Life Science, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Idiopathic Constipation

Interventions

Type	Name	Description
DRUG	YKP10811
DRUG	Placebo

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-09-01
• Completion: 2014-12-01
• First posted: 2013-11-20
• Last updated: 2014-12-19

Locations

69 sites across 1 country: United States