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Label indication MOTEGRITY ® is indicated for the treatment of chronic idiopathic constipation (CIC) in adults. MOTEGRITY is a serotonin-4 (5-HT 4 ) receptor agonist indicated for the treatment of chronic idiopathic constipation (CIC) in adults. ( 1 ) FDA label
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 to treat functional constipation, including chronic constipation in male adults and functional constipation in pediatric subjects. It is a small molecule therapeutic being developed by Takeda Pharmaceutical Company Limited for gastrointestinal conditions. The clinical program covers both adult male and pediatric patient populations.
Prucalopride targets HTR4, the serotonin 5-HT4 receptor, and acts as an agonist at this receptor. By activating HTR4, prucalopride stimulates gastrointestinal motility, which helps promote bowel movement in patients with constipation. This mechanism underlies its development for functional constipation and chronic constipation.
Prucalopride is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical trials evaluating prucalopride in functional constipation and chronic constipation in male subjects.
Prucalopride is in Phase 3 clinical development. The program includes completed Phase 3 trials in pediatric functional constipation and in male subjects with chronic constipation. It is an investigational small molecule and has not been approved by the FDA for these indications based on the available development information.
Prucalopride has been studied in two completed Phase 3 trials. NCT01330381 evaluated prucalopride in pediatric subjects with functional constipation in the Netherlands, enrolling 215 participants. NCT01147926 evaluated prucalopride in male subjects with chronic constipation across multiple European countries, enrolling 374 participants. Both trials were randomized, double-blind, and placebo-controlled.