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NCT01989234 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by SK Life Science.
- Completed
- Registry status
- Phase 2
- Development phase
- 334
- Enrollment target
NCT01989234: Completed Phase 2 study, sponsored by SK Life Science.
NCT01989234 is a Phase 2 study that has completed, run by SK Life Science. The registered enrollment target is 334 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (151% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01989234, a Phase 2 study, has completed, sponsored by SK Life Science.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 334 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG YKP10811
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 334 participants |
| Start Date | 2013-10 |
| Est. Completion | 2014-12 |
| Phase | Phase 2 |
What the finished NCT01989234 record still lists
NCT01989234 is an interventional study that assigns participants to a tested intervention. The registered 334 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (151% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01989234 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01989234 about?
NCT01989234 is a clinical study titled "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". 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 wi...
What is the current status of trial NCT01989234?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 334 participants. The study started on 2013-10. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01989234?
The interventions under investigation include: Placebo (DRUG), YKP10811 (DRUG).
Who is sponsoring clinical trial NCT01989234?
This trial is sponsored by SK Life Science, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01989234's enrollment target sits among peer trials
334 143rd of 2000 higher than 1,857 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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