Conditions: Constipation
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 127
Healthy volunteers: no

Brief summary:
The primary purpose of this study is to evaluate the safety and efficacy of lubiprostone in a pediatric population with constipation, including the pharmacokinetics of lubiprostone, in a subset of patients.

Detailed description:

Arms:
arm 1: Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (\<6 years of age and able to swallow capsules) who are at least 12 kg body weight arm 2: Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight arm 3: Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight

Interventions: intervention 1: Lubiprostone intervention 2: Lubiprostone intervention 3: Lubiprostone
Intervention descriptions: intervention 1: 12 mcg capsule once daily (QD) intervention 2: 12 mcg capsule twice daily (BID) intervention 3: 24 mcg capsule twice daily (BID)

Protocol document: