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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01147926 | Evaluation of Prucalopride in Male Subjects With Chronic Constipation. | PHASE3 | COMPLETED | 374 | — | — | Sep 23, 2010 | Oct 25, 2013 | Jun 10, 2021 | 73 | Belgium, Bulgaria +8 |
Spontaneous Bowel Movements defined as a bowel movement that is not preceded within a period of 24 hours by the intake of a laxative agent or by the use of an enema.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Prucalopride | ACTIVE_COMPARATOR | 1 milligram (mg) or 2 mg |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo matched to Prucalopride tablet orally once daily. |
| Prucalopride | DRUG | Prucalopride 2 mg tablet orally once daily for subjects greater than or equal to (≥) 18 to less than (\<) 65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4. |
Inclusion Criteria: 1. Subject is a male out-patient ≥18 years of age (no upper age limit). 2. Subject has a history of constipation. The subject reports an average of ≤ 2 SBM/week that result in a feeling of complete evacuation (SCBM) and one or more of the following for at least 6 months before t...