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Clinical trial

Trial Consisting of an 8-week Double-blind Placebo-controlled Part to Evaluate Efficacy, Safety, Tolerability and Pharmacokinetics of Prucalopride in Paediatric Subjects With Functional Constipation, Aged ≥6 Months to <18 Years, Followed by a 16-week Open-label Comparator (PEG) Controlled Part, to Document Safety and Tolerability up to 24 Weeks

NCT01330381 is registered in ClinicalTrials.gov with Shire as lead sponsor.

NCT NCT01330381
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Registry record

As filed in ClinicalTrials.gov.

Title
Trial Consisting of an 8-week Double-blind Placebo-controlled Part to Evaluate Efficacy, Safety, Tolerability and Pharmacokinetics of Prucalopride in Paediatric Subjects With Functional Constipation, Aged ≥6 Months to <18 Years, Followed by a 16-week Open-label Comparator (PEG) Controlled Part, to Document Safety and Tolerability up to 24 Weeks
Lead sponsor
Shire
Phase
Phase 3
Overall status
Completed
Start date
April 28, 2011
Completion date
March 1, 2013
Enrollment
215 (actual)
Sites
1

Conditions

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

functional constipation