Conditions: Chronic Idiopathic Constipation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 164
Healthy volunteers: no

Brief summary:
To evaluate the pharmacodynamics and tolerability of a liquid formulation of lubiprostone, as compared to matching placebo, when administered orally to subjects with chronic idiopathic constipation. Additionally, liquid formulation pharmacokinetics, including a comparison of fed and fasted pharmacokinetics, of the liquid formulation will be performed in a subset of subjects.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Lubiprostone intervention 2: Placebo
Intervention descriptions: intervention 1: Liquid formulation, 12 mcg x 2 pumps administered orally twice daily (BID) intervention 2: Matching liquid placebo, 0 mcg x 2 pumps administered orally twice daily (BID)

Protocol document: