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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 21, 2005
Last updated: September 1, 2015
Last verified: December 2011
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 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 Constipation Drug: alvimopan Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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, pharmacokinetics, pharmacogenetics (dependent on results from other data)

Enrollment: 518
Study Start Date: August 2005
Study Completion Date: May 2006
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Experimental: Alvimopan 0.5 mg once daily Drug: alvimopan
0.5 mg
Other Name: Entereg
Experimental: alvimopan 0.5 mg twice daily Drug: alvimopan
0.5 mg
Other Name: Entereg


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Has 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
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Please refer to this study by its identifier: NCT00256932

  Show 200 Study Locations
Sponsors and Collaborators
Cubist Pharmaceuticals LLC
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

Responsible Party: Cubist Pharmaceuticals LLC Identifier: NCT00256932     History of Changes
Other Study ID Numbers: SB-767905/012
Study First Received: November 21, 2005
Last Updated: September 1, 2015

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

Additional relevant MeSH terms:
Intestinal Diseases
Gastrointestinal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Digestive System Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Gastrointestinal Agents processed this record on August 22, 2017