A Multi-center, Randomized, Double-Blinded Study of the Efficacy and Safety of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction (OBD)

Sucampo Pharma Americas, LLC93 sites in 1 country439 target enrollmentAugust 2007

ConditionsOpioid-Induced Bowel Dysfunction

InterventionsPlacebo Lubiprostone

DrugsLubiprostone Placebo

Overview

Phase: Phase 3
Intervention: Placebo
Conditions: Opioid-Induced Bowel Dysfunction
Sponsor: Sucampo Pharma Americas, LLC
Enrollment: 439
Locations: 93
Primary Endpoint: Mean Weekly Spontaneous Bowel Movements at Week 8
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

August 2007

End Date

March 2009

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sucampo Pharma Americas, LLC

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Placebo

0 mcg capsules twice daily (BID)

Intervention: Placebo

Lubiprostone

24 mcg capsules twice daily (BID)

Intervention: Lubiprostone

Outcomes

Primary Outcomes

Mean Weekly Spontaneous Bowel Movements at Week 8

Time Frame: at Week 8

Spontaneous bowel movements (SBMs) are defined as bowel movements without the aid of drugs.

Secondary Outcomes

Mean Number of Spontaneous Bowel Movements (SBM) Per Week Within 12 Weeks(within 12 weeks)
Number of Participants With the First Post-dose Spontaneous Bowel Movement Within 48 Hours Post-dose(within 48 hours post-dose)
Number of Participants Classified as Responders(within 12 weeks)
Participant Reported Outcome of Treatment Effectiveness(within 12 weeks)
Mean Change From Baseline in Straining, Stool Consistency, Constipation Severity, Abdominal Bloating, Abdominal Discomfort, and Bowel Habit Regularity(within 12 weeks)