We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT00256932
Recruitment Status : Completed
First Posted : November 22, 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 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: alvimopan Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 518 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
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
Drug Information available for: Alvimopan
U.S. FDA Resources

Arm Intervention/treatment
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

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, pharmacokinetics, 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.

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.

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 ClinicalTrials.gov identifier (NCT number): NCT00256932

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

Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT00256932     History of Changes
Other Study ID Numbers: SB-767905/012
First Posted: November 22, 2005    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: December 2011

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