Pharmacodynamic, Pharmacokinetic, and Tolerability Study of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation
| Status: | Completed |
|---|---|
| Conditions: | Constipation |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2013 |
| End Date: | January 2014 |
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
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.
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.
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.
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