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Opioid-induced Bowel Dysfunction: Pivotal Assessment of Lubiprostone

NCT00595946 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 439

Last updated 2019-12-16

Study results available
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Summary

The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone administration in patients with Opioid-induced Bowel Dysfunction.

Conditions

  • Opioid-Induced Bowel Dysfunction

Interventions

DRUG

Lubiprostone

24 mcg capsules twice daily (BID)

DRUG

Placebo

0 mcg capsules twice daily (BID)

Sponsors & Collaborators

  • Sucampo Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Sucampo Pharma Americas, LLC

    lead INDUSTRY

Principal Investigators

  • Clinical Team Leader · Mallinckrodt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT00595946 on ClinicalTrials.gov