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

Sucampo

Status and phase

Completed

Phase 3

Conditions

Opioid-Induced Bowel Dysfunction

Treatments

Drug: Lubiprostone

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00595946

OBD0631

Details and patient eligibility

About

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

Enrollment

439 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.