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

NCT01993875 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2019-12-13

Study results available
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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

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)

Sponsors & Collaborators

  • Sucampo Pharma Americas, LLC

    collaborator INDUSTRY

  • Takeda

    collaborator INDUSTRY

  • Sucampo AG

    collaborator INDUSTRY

  • Mallinckrodt

    lead INDUSTRY

Principal Investigators

  • Global Clinical Leader · Mallinckrodt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01993875 on ClinicalTrials.gov