Conditions: Constipation - Functional
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 606
Healthy volunteers: no

Brief summary:
Study to determine if children (6-17 years old) with functional constipation will respond to being treated with lubiprostone for 12 weeks.

Detailed description:
Dose administration details:

* Participants with a body weight \<50 kg at baseline received Lubiprostone 12 mcg BID for 12 weeks. If the dose was safe but did not show any efficacy at Week 1, dosage was increased to 24 mcg BID.
* Participants with a body weight \>50 kg at baseline received Lubiprostone 24 mcg BID for 12 weeks. If the dose was unsafe at Week 1, dosage was decreased to 12 mcg BID.

Arms:
arm 1: Participants receive lubiprostone twice daily (BID) up to 12 weeks arm 2: Participants receive placebo BID up to 12 weeks

Interventions: intervention 1: Lubiprostone intervention 2: Placebo
Intervention descriptions: intervention 1: 12 or 24 mcg soft capsules of lubiprostone for oral administration, depending on baseline weight and response during week 1 intervention 2: 0 mcg soft capsules of placebo for oral administration

Protocol document: