A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Lubiprostone in Subjects With Opioid-induced Bowel Dysfunction
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Sucampo Pharma Americas, LLC
- Enrollment
- 439
- Locations
- 140
- Primary Endpoint
- Number of Participants Classified as Treatment Responders Within 12 Weeks
Study Overview
Brief Summary
The primary purpose of the study is to evaluate the efficacy and safety of lubiprostone administration in subjects with Opioid-induced Bowel Dysfunction.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
Care provider and outcomes assessor were also blinded for this double-blind trial.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Lubiprostone
24 mcg capsules twice daily (BID)
Intervention: Lubiprostone (Drug)
Placebo
0 mcg capsules twice daily (BID)
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Number of Participants Classified as Treatment Responders Within 12 Weeks
Time Frame: 12 weeks
Spontaneous bowel movement (SBM) is defined as any BM that does not occur within 24 hours after use of rescue medication. To be classified as responders, participants are required to demonstrate at least moderate response (≥ 1 SBM improvement over baseline SBM frequency) for all treatment weeks for which observed data are available, and must additionally demonstrate a full response (≥ 3 SBMs per week) for at least 9 of the 12 treatment weeks.
Secondary Outcomes
- Number of SBMs Per Week at Week 12(at Week 12)
- Number of Participants Who Experienced First SBM Within 48 Hours After Dose Initiation(within 48 hours post-dose)
- Number of SBMs Per Week Overall(within 14 weeks)
- Number of SBMs Per Week at Week 8(at Week 8)