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

NCT00597428

OBD0632

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 (OBD).

Enrollment: 437 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 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 inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), or monoamine oxidase (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

• Opioid dose adjustment (+/- 30%), and/or change in opioid agent or route of administration within 30 days of screening.
• Non-ambulatory patients, or those who are unable to eat/drink, take oral medications, or to hold down oral medications due to vomiting.
• 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).
• Gastrointestinal or abdominal surgical procedures within 90 days prior to screening.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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437 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

0 mcg capsules twice daily (BID)

Treatment:

Drug: Placebo

Lubiprostone

Experimental group

Description:

24 mcg capsules twice daily (BID)

Treatment:

Drug: Lubiprostone