Opioid-induced Bowel Dysfunction: Pivotal Assessment of Lubiprostone
(OPAL Trial)
Recruiting in Palo Alto (17 mi)
+94 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Sucampo Pharma Americas, LLC
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone administration in patients with Opioid-induced Bowel Dysfunction.
Research Team
CT
Clinical Team Leader
Principal Investigator
Mallinckrodt
Eligibility Criteria
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.
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Treatment Details
Interventions
- Lubiprostone (Chloride Channel Activator)
- Placebo (Other)
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: LubiprostoneExperimental Treatment1 Intervention
24 mcg capsules twice daily (BID)
Group II: PlaceboPlacebo Group1 Intervention
0 mcg capsules twice daily (BID)
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Who Is Running the Clinical Trial?
Sucampo Pharma Americas, LLC
Lead Sponsor
Trials
18
Recruited
5,200+
Sucampo Pharmaceuticals, Inc.
Industry Sponsor
Trials
11
Recruited
2,700+