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Clinical trial

Phase 3, Multicenter, Randomized Study With 2 Different Doses of Prucalopride Administered to Male and Female Pediatric Subjects Aged 6 Months to 17 Years With Functional Constipation, Consisting of a 12-week Double-blind, Placebo-controlled Part (Part A) to Evaluate Efficacy and Safety Followed by a 36-week Double-blind Extension Part (Part B) to Document Long-term Safety up to Week 48

NCT04759833 is registered in ClinicalTrials.gov with Takeda as lead sponsor.

NCT NCT04759833
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Registry record

As filed in ClinicalTrials.gov.

Title
Phase 3, Multicenter, Randomized Study With 2 Different Doses of Prucalopride Administered to Male and Female Pediatric Subjects Aged 6 Months to 17 Years With Functional Constipation, Consisting of a 12-week Double-blind, Placebo-controlled Part (Part A) to Evaluate Efficacy and Safety Followed by a 36-week Double-blind Extension Part (Part B) to Document Long-term Safety up to Week 48
Lead sponsor
Takeda
Phase
Phase 3
Overall status
Terminated
Start date
July 13, 2021
Completion date
November 13, 2023
Enrollment
175 (actual)
Sites
41

Conditions

As the registry lists them; a condition with its own page is linked.

constipation