Opioid-induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone administration in participants with opioid-induced bowel dysfunction.

Official Title
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A Multi-center, Open-labeled Study of the Long-term Safety and Efficacy of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction

Conditions
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Opioid-Induced Bowel Dysfunction

Intervention / Treatment
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* Drug: Lubiprostone 24


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has completed 12 weeks of blinded treatment in NCT00595946 or NCT00597428 Will continue to be treated consistently for chronic, non-cancer-related pain with any full agonist opiate and will continue opiate therapy for the duration of the study Willing to continue to abstain from use of disallowed medications as defined per protocol Exclusion Criteria: Has newly diagnosed impaired renal function identified at the Screening Visit [i.e., serum creatinine concentration > 1.8 milligrams per deciliter (mg/dL)] Has experienced an unexplained and/or clinically significant weight loss defined as > 5% within 90 days prior to Screening Visit. Has plans to participate in another trial with an investigational drug or device during the course of the extension study

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All Participants<br>Lubiprostone: 24 mcg capsule twice daily (BID) for 36 weeks | Drug: Lubiprostone 24<br>* 24 mcg capsules for oral administration<br>* Other names: Amitiza;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month | A Spontaneous Bowel Movement (SBM) is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication. | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | 
| Mean Weekly Bowel Movements (BMs) Per Month | A Bowel Movement (BM) is defined as any BM (whether spontaneous or not) | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Classified as Monthly Responders | A weekly SBM frequency rate is calculated as (168 x Number of SBMs / Number of hours observed). A participant with an SBM frequency rate between 3 and 4 was considered a moderate responder. A subject with an SBM frequency rate higher than 4 was considered a full responder. If a subject was a moderate responder or full responder for at least half the weeks in a month, then he or she was considered a monthly responder. | Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | 
| Straining Associated With Spontaneous Bowel Movements by Month | Participants rate the straining associated with the SBM on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe The highest score is 4, and lower scores are better. | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | 
| Stool Consistency of Spontaneous Bowel Movements by Month | Participants rate each spontaneous bowel movement on a scale where 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) The highest score is 4, but the best score is 2. | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | 
| Constipation Severity by Month | Participants rate the severity of their constipation on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The highest score is 4, but the best score is 0. | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | 
| Abdominal Bloating by Month | Participants rate their bloating on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The highest score is 4, but the best score is 0. | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | 
| Abdominal Discomfort by Month | Participants rate their abdominal discomfort on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The highest score is 4, but the best score is 0. | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | 
| Bowel Habit Regularity by Month | Participants rate their bowel habit regularity on a balanced scale of 1 to 7 where 1=Very Regular and 7=Very Irregular. The highest score is 7, but the best score is 1. | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | 
| Treatment Effectiveness by Month | Participants rate treatment effectiveness on a scale where 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective. The highest and best score is 4. | Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | 
| Mean Weekly Complete SBMs by Month | Participants rate each SBM as complete if their bowels feel completely empty after the SBM | Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | 
| Mean Weekly Complete BMs by Month | Participants rate each BM as complete if their bowels feel completely empty after the BM | Months 1, 2, 3, 4, 5, 6, 7, 8, and 9 |