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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00259922
First received: November 29, 2005
Last updated: March 6, 2009
Last verified: March 2009
History of Changes

November 29, 2005
March 6, 2009
August 2005
Not Provided
To compare alvimopan with placebo for efficacy in the treatment of OBD
To compare alvimopan with placebo for efficacy in the treatment of OBD
Complete list of historical versions of study NCT00259922 on ClinicalTrials.gov Archive Site
Safety and tolerability, quality of life, pharmacogenetics (dependent on results from other data)
Safety and tolerability, quality of life, pharmacogenetics (dependent on results from other data)
Not Provided
Not Provided
 
Alvimopan For The Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain
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

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Bowel Dysfunction
  • Constipation
Drug: alvimopan
Other Name: alvimopan
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
480
Not Provided
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   France,   Hungary,   Netherlands,   New Zealand,   Norway,   South Africa,   Spain,   Sweden,   Switzerland
 
NCT00259922
SB-767905/013
Not Provided
Study Director, GSK
Cubist Pharmaceuticals
GlaxoSmithKline
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
Cubist Pharmaceuticals
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP