Long-Term Safety Evaluation Of Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain

Study Overview
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Brief Summary
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Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1) to alvimopan or placebo. The primary objective of this Phase 3 long-term safety study is to compare alvimopan with placebo for safety and tolerability in the treatment of OBD. Participants will be required to attend 8 clinic visits over approximately 1 year.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate Long-Term Safety and Efficacy of Alvimopan 0.5mg Twice Daily for 12 Months for the Treatment of Opioid-Induced Bowel Dysfunction in Adults Taking Opioid Therapy for Persistent Non-Cancer Pain

Conditions
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Bowel Dysfunction, Constipation

Intervention / Treatment
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* Drug: Alvimopan
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Consented to participate in this study. Taking opioid therapy for persistent non-cancer pain. Has bowel dysfunction mainly due to opioids. Has bowel dysfunction since starting opioids as defined by infrequent bowel movements and additional bowel-related symptoms. Willing to discontinue laxative therapy (will be provided study-specific standardized laxative if needed). Exclusion criteria: Pregnant, lactating, or planning to become pregnant. Not ambulatory. Participated in another trial with an investigational drug in the past 30 days. Taking opioids for the management of drug addiction or cancer-related pain. Severe constipation whereby the subject is at immediate risk of developing serious complications of constipation. Gastrointestinal or pelvic disorders known to affect bowel transit, produce gastrointestinal (GI) obstruction, or contribute to bowel dysfunction. Human Immunodeficiency Virus (HIV)-infected, has active hepatitis, or has ever been infected with hepatitis C.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alvimopan 0.5 mg Twice Daily (BID)<br>0.5 milligrams (mg) of alvimopan was administered orally twice daily (BID) for 12 months. | Drug: Alvimopan<br> <br> |
| Placebo Comparator: Placebo<br>Placebo was administered orally BID for 12 months. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare alvimopan with placebo for long-term safety and tolerability |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life, pharmacokinetics, pharmacogenetics (dependent on results from other data) |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bowel dysfunction, constipation, gastrointestinal, opioids, pain, non-cancer pain, opioid-induced