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Comparison of Lubiprostone and Placebo for the Relief of Constipation From Constipating Medications

NCT01096290 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2020-11-20

Study results available
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Summary

Constipation from medications is a serious and common condition. Lubiprostone has properties that make it a candidate drug. One hundred volunteers with constipation who are taking medications known to cause constipation will be randomized to take lubiprostone or placebo for 28 days. Therapeutic outcome will be evaluated by investigator and study subject assessment.

Conditions

Interventions

DRUG

lubiprostone

24mcg BID, capsule, oral 30days

DRUG

Matched placebo

Twice daily for 30days, oral

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Sucampo Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • University of South Alabama

    lead OTHER

Principal Investigators

  • Jack A DiPalma, M.D. · University of South Alabama College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

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Entities

Diseases
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 NCT01096290 on ClinicalTrials.gov