MedTrace Logo

Opioid-induced Bowel Dysfunction (OBD) Pivotal Assessment of Lubiprostone (OPAL)

NCT01298219 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 439

Last updated 2020-02-11

Study results available
· View outcomes & findings →

Summary

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

Conditions

  • Opioid-induced Bowel Dysfunction

Interventions

DRUG

Lubiprostone

24 mcg administered orally twice daily (BID)

DRUG

Placebo

Matching placebo, 0 mcg administered orally twice daily (BID)

Sponsors & Collaborators

  • Sucampo Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Sucampo Pharma Americas, LLC

    lead INDUSTRY

Principal Investigators

  • Clinical Study Leader · Mallinckrodt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • United States
  • Belgium
  • Czechia
  • Germany
  • Poland
  • Sweden
  • United Kingdom

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 NCT01298219 on ClinicalTrials.gov