NCT01993875

Pharmacodynamic, Pharmacokinetic, and Tolerability Study of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation

A Randomized, Placebo-controlled, Double-blinded, Multicenter Study of the Pharmacodynamics, Pharmacokinetics, and Tolerability of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Idiopathic Constipation

Interventions

Type	Name	Description
DRUG	Lubiprostone	Liquid formulation, 12 mcg x 2 pumps administered orally twice daily (BID)
DRUG	Placebo	Matching liquid placebo, 0 mcg x 2 pumps administered orally twice daily (BID)

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2013-11-25
• Last updated: 2019-12-13
• Results posted: 2019-12-13

Locations

11 sites across 1 country: United States