Don't get left behind! The modernized is coming. Check it out now.
Say goodbye to!
The new site is coming soon - go to the modernized
Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00259922
Recruitment Status : Completed
First Posted : December 1, 2005
Last Update Posted : September 2, 2015
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC

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.

Condition or disease Intervention/treatment Phase
Bowel Dysfunction Constipation Drug: Placebo Drug: Alvimopan Drug: Alviompan Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 485 participants
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
Study Start Date : August 2005
Actual Primary Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
Drug Information available for: Alvimopan

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00259922

Show Show 187 study locations
Sponsors and Collaborators
Cubist Pharmaceuticals LLC
Layout table for investigator information
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
Publications of Results:
Layout table for additonal information
Responsible Party: Cubist Pharmaceuticals LLC Identifier: NCT00259922    
Other Study ID Numbers: SB-767905/013
First Posted: December 1, 2005    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: September 2009
Keywords provided by Cubist Pharmaceuticals LLC:
non-cancer pain
bowel dysfunction
Additional relevant MeSH terms:
Layout table for MeSH terms
Intestinal Diseases
Gastrointestinal Diseases
Signs and Symptoms, Digestive
Digestive System Diseases
Gastrointestinal Agents