Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Prucalopride · 1 trial · 1 indication
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...
Prucalopride is used for the treatment of constipation. It is a small molecule being developed by Johnson & Johnson for this gastrointestinal condition. The drug has completed a Phase 3 clinical trial in participants with chronic constipation.
Prucalopride is a small molecule that targets the gastrointestinal system to treat constipation. It is being developed by Johnson & Johnson for this condition. The drug has completed a Phase 3 clinical trial in participants with chronic constipation.
Prucalopride is being developed by Johnson & Johnson, a company traded under the ticker JNJ. The drug is a small molecule intended for the treatment of constipation. It has completed a Phase 3 clinical trial in participants with chronic constipation.
Prucalopride is in Phase 3 of clinical development. It has completed a Phase 3 clinical trial in participants with chronic constipation. The drug is being developed by Johnson & Johnson for the treatment of constipation. It is not yet approved and remains investigational.
Prucalopride has been studied in one clinical trial, NCT01116206, titled 'An Efficacy and Safety Study of Prucalopride in Participants With Chronic Constipation.' This Phase 3 trial was completed and enrolled 507 participants. It was a randomized, double-blind, placebo-controlled study conducted in Australia, China, South Korea, Taiwan, and Thailand.
Prucalopride is not FDA approved. It is an investigational drug in clinical development for the treatment of constipation. The drug has completed a Phase 3 clinical trial, but approval status has not been established. It is being developed by Johnson & Johnson.