Phase 3 N=439 Randomized Double-blind Treatment

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

Opioid-induced Bowel Dysfunction

Bottom Line

View on ClinicalTrials.gov: NCT01298219 ↗

Enrolled (actual)

439

Serious AEs

3.0%

Results posted

Dec 2019

Primary outcome: Primary: Number of Participants Classified as Treatment Responders Within 12 Weeks — 59; 41 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Lubiprostone (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Sucampo Pharma Americas, LLC
Primary completion: Nov 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Classified as Treatment Responders Within 12 Weeks	59; 41	—
SECONDARY Number of SBMs Per Week at Week 8	2.9; 2.5	—
SECONDARY Number of Participants Who Experienced First SBM Within 48 Hours After Dose Initiation	110; 84; 157; 134	—
SECONDARY Number of SBMs Per Week at Week 12	3.1; 2.7	—
SECONDARY Number of SBMs Per Week Overall	4.3; 3.7	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01298219). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.