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

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mallinckrodt; Sucampo AG
• Collaborators: Sucampo AG; Sucampo Pharma Americas, LLC; Takeda
• Treatments: Lubiprostone

Criteria

Inclusion Criteria:

• Medically-confirmed diagnosis of chronic idiopathic constipation

• Willing to discontinue use of prescribed or over-the-counter (OTC) medication that affects gastrointestinal motility during the study

• Stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors

Exclusion Criteria:

• Any gastrointestinal (GI) condition, other than constipation, affecting GI motility or defecation.

• Medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication.