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

Sucampo

Status and phase: Completed; Phase 3

Conditions: Opioid-induced Bowel Dysfunction

Treatments: Drug: Placebo; Drug: Lubiprostone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01298219

OBD1033

Details and patient eligibility

About

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

Enrollment: 439 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

A patient can be considered for eligibility to participate if he/she:

• Has been consistently treated for chronic, noncancer-related pain with any oral, transdermal, intravenous, or subcutaneous opioid for at least 30 days prior to screening
• Is diagnosed with OBD
• Is capable of utilizing an electronic diary to report daily spontaneous bowel movements (SBMs)
• Is willing to continue opioid therapy and discontinue the use of laxatives, stool softeners, and other concomitant medications affecting gastrointestinal motility throughout the study

Exclusion criteria

A patient cannot be considered for eligibility to participate if he/she:

• Uses opioids for the treatment of cancer-related pain, abdominal pain, mechanical bowel obstructions, bowel disorders, and constipation not arising from opioid use, but instead attributable to dietary, neurologic, congenital, or endocrine disorders, scleroderma, and/or for the management of drug addiction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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439 participants in 2 patient groups, including a placebo group

Lubiprostone

Experimental group

Description:

24 mcg capsules twice daily (BID)

Treatment:

Drug: Lubiprostone

Placebo

Placebo Comparator group

Description:

0 mcg capsules twice daily (BID)

Treatment:

Drug: Placebo