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

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

Official Title
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A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Lubiprostone in Subjects With Opioid-induced Bowel Dysfunction

Conditions
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Opioid-induced Bowel Dysfunction

Intervention / Treatment
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* Drug: Lubiprostone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lubiprostone<br>24 mcg capsules twice daily (BID) | Drug: Lubiprostone<br>* 24 mcg administered orally twice daily (BID)<br>* Other names: Amitiza;|
| Placebo Comparator: Placebo<br>0 mcg capsules twice daily (BID) | Drug: Placebo<br>* Matching placebo, 0 mcg administered orally twice daily (BID)<br>* Other names: No other names;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Classified as Treatment Responders Within 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of SBMs Per Week at Week 8 |  | at Week 8 | 
| Number of Participants Who Experienced First SBM Within 48 Hours After Dose Initiation |  | within 48 hours post-dose | 
| Number of SBMs Per Week at Week 12 |  | at Week 12 | 
| Number of SBMs Per Week Overall | Overall is defined as the length of time from first dose to last follow-up within 2 weeks after last dose. | within 14 weeks |