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Opioid-induced Bowel Dysfunct...

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

NCT ID: NCT00620061

Last Updated: 2020-01-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

439 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-09-30

Brief Summary

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

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Detailed Description

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Conditions

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Opioid-Induced Bowel Dysfunction

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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All Participants

Lubiprostone: 24 mcg capsule twice daily (BID) for 36 weeks

Group Type EXPERIMENTAL

Lubiprostone 24

Intervention Type DRUG

24 mcg capsules for oral administration

Interventions

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Lubiprostone 24

24 mcg capsules for oral administration

Intervention Type DRUG

Other Intervention Names

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Amitiza

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Leader

Role: STUDY_DIRECTOR

Mallinckrodt

Locations

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The Birmingham Pain Center

Birmingham, Alabama, United States

Site Status

Simon Williamson Clinic, PC

Hueytown, Alabama, United States

Site Status

Alabama Orthopedic Clinic

Mobile, Alabama, United States

Site Status

Clinical Research Advantage, Inc./ Mesa Family Medical Center

Mesa, Arizona, United States

Site Status

Redpoint Research

Phoenix, Arizona, United States

Site Status

HOPE Research Institute

Phoenix, Arizona, United States

Site Status

Clinical Research Advantage, Inc.

Phoenix, Arizona, United States

Site Status

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

Tempe, Arizona, United States

Site Status

Clinical Research Advantage, Inc.

Tempe, Arizona, United States

Site Status