Prucalopride in Pediatric Subjects With Functional Constipation

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Collaborator: PRA Health Sciences
• Treatments: Prucalopride

Criteria

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. Constipation is thought to be drug-induced.

3. Subjects suffering from secondary causes of chronic constipation.