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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01116206 | An Efficacy and Safety Study of Prucalopride in Participants With Chronic Constipation | PHASE3 | COMPLETED | 507 | — | — | May 1, 2010 | Mar 1, 2011 | Mar 21, 2017 | 27 | Australia, China +3 |
Percentage of responders (responders: participants with an average of 3 or more SCBMs per week) will be assessed during 12-week double-blind treatment phase (total treatment duration). SCBM is defined as a Spontaneous Bowel Movement (SBM) associated with a sense of complete evacuation. SBM is defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository used on either the calendar day of the BM or the calendar day before the BM. The total number of SBMs associated with a feeling of complete evacuation will be summed and divided by 12. Average weekly frequency of SCBMs will be calculated as number of SCBMs in treatment phase multiplied by 7 divided by total number of evaluable days in treatment phase.
| Arm | Type | Description |
|---|---|---|
| Prucalopride | EXPERIMENTAL | prucalopride 2- milligram (mg), orally once daily for 12 weeks |
| Placebo | PLACEBO_COMPARATOR | Matching placebo, orally once daily for 12 weeks |
| Name | Type | Description |
|---|---|---|
| Prucalopride | DRUG | 2 mg tablet, orally once daily, for 12 weeks |
| Placebo | DRUG | 1 tablet, orally once dailyfor 12 weeks |
Inclusion Criteria: * History of chronic constipation, defined as on average, 2 or fewer spontaneous bowel movements (SBMs) per week and 1 or more of the following for at least a quarter of the time for the last 3 months, while symptom onset was more than 6 months before the screening visit: in mor...