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

This study has been completed.
Information provided by:
Cubist Pharmaceuticals Holdings LLC Identifier:
First received: November 21, 2005
Last updated: March 6, 2009
Last verified: March 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 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: alvimopan
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 Holdings 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)

Estimated Enrollment: 480
Study Start Date: August 2005
Intervention Details:
    Drug: alvimopan
    Other Name: alvimopan

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

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

No publications provided

Responsible Party: Study Director, GSK Identifier: NCT00256932     History of Changes
Other Study ID Numbers: SB-767905/012
Study First Received: November 21, 2005
Last Updated: March 6, 2009
Health Authority: United States: Food and Drug Administration

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

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 August 03, 2015