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Prucalopride · 2 trials · 2 indications
Responders are defined as subjects with an average spontaneous defecation frequency is ≥3 times per week AND the average number of fecal incontinence episodes per 2 weeks is ≤ 1 episode (only for subjects after acquisition of toileting skills).
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 |
|---|---|---|
| prucalopride | EXPERIMENTAL | drug |
| Placebo | PLACEBO_COMPARATOR | - |
| PEG 4000 | ACTIVE_COMPARATOR | 4-20g administered as an oral solution once daily |
| Name | Type | Description |
|---|---|---|
| prucalopride | DRUG | prucalopride * subjects with weight ≤50kg: 0.04 mg/kg once daily as oral solution of 0.4 mg/ml * subjects with weight \>50 kg: prucalopride 2 mg tablet once daily |
| Placebo | DRUG | Matching oral solution or oral tablets given once daily |
| PEG 4000 | DRUG | - |
Main Inclusion Criteria: 1. Boys and girls, aged ≥ 6 months and \< 18 years. 2. Subjects with a confirmed diagnosis of functional constipation as defined by the Rome III criteria. Main Exclusion Criteria: 1. Children with underlying GI abnormalities and causes for defecation disorders. 2. Constip...
Prucalopride is used for chronic constipation and functional constipation. It has been evaluated in male subjects with chronic constipation and in pediatric subjects with functional constipation. It is a small molecule being developed for gastrointestinal conditions.
Prucalopride is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials for this drug in gastrointestinal indications.
Prucalopride is in Phase 3 clinical development. It has completed Phase 3 trials for chronic constipation in male subjects and for functional constipation in pediatric subjects. It remains an investigational drug in clinical development.
Prucalopride has completed two Phase 3 trials. NCT01147926 evaluated Prucalopride in 374 male subjects with chronic constipation across multiple European countries. NCT01330381 evaluated Prucalopride in 215 pediatric subjects with functional constipation in the Netherlands.
Prucalopride is a distinct small molecule developed by Takeda for chronic constipation and functional constipation. It has been studied in placebo-controlled, double-blind, randomized Phase 3 trials, including in male adults and pediatric patients.