Long-Term Safety Evaluation Of 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
ClinicalTrials.gov Identifier:
First received: October 17, 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) to alvimopan or placebo. The primary objective of this Phase 3 long-term safety study is to compare alvimopan with placebo for safety and tolerability in the treatment of OBD. Participants will be required to attend 8 clinic visits over approximately 1 year.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety 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 Long-Term Safety and Efficacy of Alvimopan 0.5mg Twice Daily for 12 Months 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 long-term safety and tolerability [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Quality of life, pharmacokinetics, pharmacogenetics (dependent on results from other data) [ Time Frame: 12 months ]

Enrollment: 805
Study Start Date: August 2005
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alvimopan 0.5 mg Twice Daily (BID)
0.5 milligrams (mg) of alvimopan was administered orally twice daily (BID) for 12 months.
Drug: Alvimopan
Placebo Comparator: Placebo
Placebo was administered orally BID for 12 months.
Drug: Placebo


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).

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.
  • Human Immunodeficiency Virus (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 ClinicalTrials.gov identifier: NCT00241722

  Show 227 Study Locations
Sponsors and Collaborators
Cubist Pharmaceuticals LLC
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT00241722     History of Changes
Other Study ID Numbers: SB-767905/014
Study First Received: October 17, 2005
Last Updated: September 1, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Cubist Pharmaceuticals 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

ClinicalTrials.gov processed this record on November 27, 2015