Prucalopride in Pediatric Subjects With Functional Constipation (FC)

Shire

Status and phase: Completed; Phase 3

Conditions: Functional Constipation

Treatments: Drug: prucalopride; Drug: PEG 4000; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01330381

2010-022402-40 (EudraCT Number)

M0001-C303 (Other Identifier)

SPD555-303

Details and patient eligibility

About

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.

Enrollment: 215 patients

Sex: All

Ages: 6 months to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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215 participants in 3 patient groups, including a placebo group

prucalopride

Experimental group

Description:

drug

Treatment:

Drug: prucalopride

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

PEG 4000

Active Comparator group

Description:

4-20g administered as an oral solution once daily

Treatment:

Drug: PEG 4000