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Efficacy and Safety of Lubiprostone in Patients With Irritable Bowel Syndrome With Constipation

NCT00399542 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 581

Last updated 2019-12-17

Study results available
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Summary

The primary purpose of this study is to evaluate the efficacy and safety of administration of lubiprostone in patients with irritable bowel syndrome with constipation.

Conditions

Interventions

DRUG

Lubiprostone

DRUG

Placebo

Sponsors & Collaborators

  • Sucampo Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Sucampo Pharma Americas, LLC

    lead INDUSTRY

Principal Investigators

  • Medical Monitor, MD · Sucampo Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2006-07-31
Completion
2006-07-31

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Diseases

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 NCT00399542 on ClinicalTrials.gov