CompletedPhase 3

Prucalopride in Pediatric Subjects With Functional Constipation

Netherlands215 participantsStarted 2011-04-28

Plain-language summary

To evaluate the efficacy of prucalopride compared to placebo for the treatment of functional constipation in a paediatric population, aged ≥ 6 months to \< 18 years. A 16-week open-label comparator (PEG) controlled part will follow, to document safety and tolerability up to 24 weeks.

Who can participate

Age range6 Months – 17 Years

SexALL

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Inclusion criteria

✓. Boys and girls, aged ≥ 6 months and \< 18 years.
✓. Subjects with a confirmed diagnosis of functional constipation as defined by the Rome III criteria.

Exclusion criteria

✕. Children with underlying GI abnormalities and causes for defecation disorders.
✕. Constipation is thought to be drug-induced.
✕. Subjects suffering from secondary causes of chronic constipation.

What they're measuring

Percent of Responders in the Last Four Weeks of the Double-Blind Treatment Period

Timeframe: Last 4 weeks of double-blind treatment period

Trial details

NCT IDNCT01330381

SponsorShire

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-03-01

Results submitted2014-01-07

View on ClinicalTrials.gov More Functional Constipation trials