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Opioid-induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone | Clinical Trials | Clareo Health

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Opioid-induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone

A Multi-center, Open-labeled Study of the Long-term Safety and Efficacy of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction

NCT00620061•Sucampo Pharma Americas, LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone administration in participants with opioid-induced bowel dysfunction.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Has completed 12 weeks of blinded treatment in NCT00595946 or NCT00597428
•Will continue to be treated consistently for chronic, non-cancer-related pain with any full agonist opiate and will continue opiate therapy for the duration of the study
•Willing to continue to abstain from use of disallowed medications as defined per protocol

Exclusion Criteria

•Has newly diagnosed impaired renal function identified at the Screening Visit \[i.e., serum creatinine concentration \> 1.8 milligrams per deciliter (mg/dL)\]
•Has experienced an unexplained and/or clinically significant weight loss defined as \> 5% within 90 days prior to Screening Visit.
•Has plans to participate in another trial with an investigational drug or device during the course of the extension study

Locations (123)

The Birmingham Pain Center

Birmingham, Alabama, United States

Simon Williamson Clinic, PC

Hueytown, Alabama, United States

Alabama Orthopedic Clinic

Mobile, Alabama, United States

Clinical Research Advantage, Inc./ Mesa Family Medical Center

Mesa, Arizona, United States

Redpoint Research

Phoenix, Arizona, United States

HOPE Research Institute

Phoenix, Arizona, United States

Clinical Research Advantage, Inc.

Phoenix, Arizona, United States

Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC

Tempe, Arizona, United States

Clinical Research Advantage, Inc.

Tempe, Arizona, United States

Premiere Pharamaceutical Research, LLC

Tempe, Arizona, United States

Key Dates

Start Date

December 1, 2007

Primary Completion Date

September 1, 2009

Completion Date

September 1, 2009

Last Updated

January 21, 2020

Enrollment

439

ACTUAL participants

Conditions

Opioid-Induced Bowel Dysfunction

Interventions

Lubiprostone 24

DRUG

The Efficacy of Acupressure in Managing Opioid-induced Constipation

NCT04876508

Opioid-induced Bowel DysfunctionConstipation Drug Induced

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 21, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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