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

ID: NCT00256932
Status: Completed
Phase: Phase 3
Start Date: August 01, 2005
First Submitted: November 21, 2005
Last Updated: September 01, 2015
Results: N/A
Sponsors & Collaborators: Cubist Pharmaceuticals LLC, GlaxoSmithKline
Location: Austria, Canada, Denmark, Estonia, Finland, Germany, Ireland, Poland, United Kingdom, United States
Conditions: Bowel Dysfunction, Constipation
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Study Description

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.

Detailed Description

Condition or disease Intervention/treatment Phase

Bowel Dysfunction

Constipation

Drug: alvimopan
Other Names
Entereg
Drug: Placebo
Other Names
Phase 3

Tracking Information

First Submitted DateNovember 21, 2005
Last Update Posted DateSeptember 01, 2015
Start DateAugust 01, 2005
Actual Completion DateMay 01, 2006
Primary Completion DateN/A
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • to compare alvimopan with placebo for efficacy in the treatment of OBD

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Safety and tolerability, quality of life, pharmacokinetics, pharmacogenetics (dependent on results from other data)

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleTreatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain
Official TitleA 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
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.

Detailed Description

Study TypeInterventional
Study PhasePhase 3
Estimated Enrollment
518
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Quadruple
Primary Purpose
Treatment
Conditions
Bowel Dysfunction
Constipation
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: alvimopan

0.5 mg

Other Names
Entereg
Drug: Placebo

Other Names
Study Groups/Cohorts
Placebo

Alvimopan 0.5 mg once daily

alvimopan 0.5 mg twice daily

Study Arms
Experimental Alvimopan 0.5 mg once daily
Drug : alvimopan
0.5 mg

Experimental alvimopan 0.5 mg twice daily
Drug : alvimopan
0.5 mg

Placebo Comparator Placebo
Drug : Placebo

Arm Intervention/Treatment
Experimental Alvimopan 0.5 mg once daily
Drug : alvimopan
Experimental alvimopan 0.5 mg twice daily
Drug : alvimopan
Placebo Comparator Placebo
Drug : Placebo

Recruitment Information

Recruitment Status:Completed
Enrollment518
Completion DateMay 01, 2006
Eligibility Criteria: 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.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Austria
Canada
Denmark
Estonia
Finland
Germany
Ireland
Poland
United Kingdom
United States

Administrative Information

NCT Number:NCT00256932
Other Study ID Numbers
SB-767905/012
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Cubist Pharmaceuticals LLC
Collaborators
GlaxoSmithKline
Investigators
Study Director
GSK Clinical Trials, MD
GlaxoSmithKline