Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02695719 | Lubiprostone for Treatment of Chronic Idiopathic Constipation | PHASE3 | COMPLETED | 156 | — | — | Apr 14, 2016 | Feb 24, 2017 | Dec 31, 2018 | 5 | South Korea |
| NCT01469819 | Lubiprostone Effect on Gastrointestinal Tract Transit Times Measured by Smartpill in Patients With Chronic Constipation | PHASE2 | COMPLETED | 37 | — | — | Jun 1, 2012 | Feb 1, 2015 | Jun 9, 2017 | 1 | United States |
A SBM was defined as any bowel movement (BM) that does not occur within 24 hours after rescue medication use (laxative, suppository, or enema). Participants will be given a diary to complete at home where they will record all details of each SBM including the consistency of the stool and the difficulty they have in passing it.
The change in transit time (TT), in hours and minutes, of gastric emptying (GE), small bowel (SB), large bowel (LB) and whole gut (WG) measured by SmartPill in 29 patients with chronic constipation after taking lubiprostone 24 micrograms twice a day (BID) for 2 weeks.
| Arm | Type | Description |
|---|---|---|
| Lubiprostone 24 μg | EXPERIMENTAL | Lubiprostone 24 μg, capsules, orally, twice daily, under fed conditions, for 4 weeks. |
| Placebo | PLACEBO_COMPARATOR | Lubiprostone placebo-matching capsules, orally, twice daily, under fed conditions, for 4 weeks. |
| Lubiprostone | EXPERIMENTAL | Lubiprostone 24 mcg by mouth twice a day (BID) for 2 weeks. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Lubiprostone placebo-matching capsules |
| Lubiprostone | DRUG | Lubiprostone capsules |
Inclusion Criteria: 1. In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements. 2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any requi...