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

This study has been completed.
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC Identifier:
First received: November 29, 2005
Last updated: September 1, 2015
Last verified: September 2009
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.

Condition Intervention Phase
Bowel Dysfunction
Drug: Placebo
Drug: Alvimopan
Drug: Alviompan
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Cubist Pharmaceuticals LLC:

Primary Outcome Measures:
  • To compare alvimopan with placebo for efficacy in the treatment of OBD

Secondary Outcome Measures:
  • Safety and tolerability, quality of life, pharmacogenetics (dependent on results from other data)

Enrollment: 485
Study Start Date: August 2005
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Experimental: Alvimopan 0.5 mg once daily
0.5 mg once daily (QD)
Drug: Alvimopan
0.5 mg QD
Other Name: Entereg
Experimental: Alvimopan 0.5 mg twice daily
0.5 mg twice daily (BID)
Drug: Alviompan
0.5 mg BID
Other Name: Entereg


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00259922

  Show 187 Study Locations
Sponsors and Collaborators
Cubist Pharmaceuticals LLC
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

Responsible Party: Cubist Pharmaceuticals LLC Identifier: NCT00259922     History of Changes
Other Study ID Numbers: SB-767905/013 
Study First Received: November 29, 2005
Last Updated: September 1, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Cubist Pharmaceuticals LLC:
non-cancer pain
bowel dysfunction

Additional relevant MeSH terms:
Gastrointestinal Diseases
Intestinal Diseases
Digestive System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses processed this record on May 01, 2016