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NCT00595946

Opioid-induced Bowel Dysfunction: Pivotal Assessment of Lubiprostone

Last Updated: 2019-12-16

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

2007-08-31

Study Completion Date

2009-03-31

Brief Summary

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

Detailed Description

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Conditions

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Opioid-Induced Bowel Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

0 mcg capsules twice daily (BID)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0 mcg capsules twice daily (BID)

Lubiprostone

24 mcg capsules twice daily (BID)

Group Type EXPERIMENTAL

Lubiprostone

Intervention Type DRUG

24 mcg capsules twice daily (BID)

Interventions

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Lubiprostone

24 mcg capsules twice daily (BID)

Intervention Type DRUG

Placebo

0 mcg capsules twice daily (BID)

Intervention Type DRUG

Other Intervention Names

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Amitiza® No other names

Eligibility Criteria

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Inclusion Criteria

* Consistent treatment for chronic, non-cancer-related pain with any full agonist opioid for at least 30 days prior to screening.
* Diagnosis of opioid-induced bowel dysfunction (OBD) as confirmed during the screening period.
* If patient has a history of chronic constipation, condition must have been exacerbated by initiation of opioid treatment.
* Use of prescribed or Over-the-Counter (OTC) medication that affects gastrointestinal motility (other than opioid therapy) must be discontinued during the study.
* If treated for clinical depression with Selective serotonin reuptake inhibitor (SSRIs), Serotonin-norepinephrine reuptake inhibitor (SNRIs), or Monoamine oxidase inhibitor (MAO) inhibitors, treatment must have been at a stable dose for at least 30 days prior to screening.
* Use of laxative and stool softeners (with the exception of approved rescue medications) must be discontinued while on study.

Exclusion Criteria

* Treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction.
* Patient has been treated for cancer in the past 5 years (with the exception of localized basal cell, squamous cell skin cancer, or in situ cancer that has been resected).
* Opioid dose adjustment (+/- 30%), and/or change in opioid agent or route of administration within 30 days of screening.
* Gastrointestinal or abdominal surgical procedures within 90 days prior to screening.
* Non-ambulatory patients, or those who are unable to eat/drink, take oral medications, or to hold down oral medications due to vomiting.
* Female patients of childbearing potential who are unable/unwilling to use protocol-specified method(s) of birth control and/or are pregnant, nursing, or plan to become pregnant or nurse during the study.
* Prior use of Amitiza, lubiprostone, SPI-0211, or RU-0211.

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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Clinical Team 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