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 range

6 Months – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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