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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 is a Phase 2 study that has completed, run by SK Life Science. The registered enrollment target is 334 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01989234
The ClinicalTrials.gov registry entry for NCT01989234 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 334 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SK Life Science, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01989234 reports 0 study locations.
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.
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