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

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)485 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

485

Conditions

Bowel Dysfunction Constipation

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (187)

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Huntsville, Alabama, United States

GSK Investigational Site

Mobile, Alabama, United States

GSK Investigational Site

Northport, Alabama, United States

Outcomes

Primary Outcomes

To compare alvimopan with placebo for efficacy in the treatment of OBD

Secondary Outcomes

Safety and tolerability, quality of life, pharmacogenetics (dependent on results from other data)