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

Mallinckrodt

Status and phase: Completed; Phase 3

Conditions: Chronic Idiopathic Constipation

Treatments: Drug: Placebo; Drug: Lubiprostone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01993875

SCMP-0211-301

Details and patient eligibility

About

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.

Enrollment: 164 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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164 participants in 2 patient groups, including a placebo group

Lubiprostone

Experimental group

Treatment:

Drug: Lubiprostone

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo