Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2026-02-27 @ 10:20 AM
Study NCT ID:
NCT01989234
Status:
COMPLETED
Last Update Posted:
2014-12-19
First Post:
2013-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
SK Life Science, Inc.
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: