Alvimopan For The Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain

Study Overview
=================
Brief Summary
-----------------
Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one of 2 alvimopan arms, or to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint is based on frequency of bowel movements. Subjects will be required to: (1) track their bowel movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months.

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

Conditions
-----------------
Constipation, Bowel Dysfunction

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Alvimopan
* Drug: Alviompan


Participation Criteria
=================
Eligibility Criteria
-----------------
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). Willing to report daily bowel symptoms. 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. HIV-infected, has active hepatitis, or has ever been infected with hepatitis C.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|
| Experimental: Alvimopan 0.5 mg once daily<br>0.5 mg once daily (QD) | Drug: Alvimopan<br>* 0.5 mg QD<br>* Other names: Entereg;|
| Experimental: Alvimopan 0.5 mg twice daily<br>0.5 mg twice daily (BID) | Drug: Alviompan<br>* 0.5 mg BID<br>* Other names: Entereg;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare alvimopan with placebo for efficacy in the treatment of OBD |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability, quality of life, pharmacogenetics (dependent on results from other data) |  |  | 

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