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

Completed · Phase 3 · Has a placebo group

Conditions studied: Chronic Idiopathic Constipation

In brief

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.

Key facts

Study ID

NCT01993875

Run by

Mallinckrodt

People needed

164

Starts

2013-10-01

Expected to finish

2014-01-01

Last updated by the study team

2019-12-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Study site — Anniston, Alabama, United States
• Study site — Anaheim, California, United States
• Study site — DeLand, Florida, United States
• Study site — Hollywood, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — South Miami, Florida, United States
• Study site — Overland Park, Kansas, United States
• Study site — Marlton, New Jersey, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Salt Lake City, Utah, United States
• Study site — West Bend, Wisconsin, United States

Full record on ClinicalTrials.gov

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