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

ID: NCT00259922
Status: Completed
Phase: Phase 3
Start Date: August 01, 2005
First Submitted: November 29, 2005
Last Updated: September 01, 2015
Results: N/A
Sponsors & Collaborators: Cubist Pharmaceuticals LLC, GlaxoSmithKline
Location: Australia, Canada, France, Hungary, Netherlands, New Zealand, Norway, South Africa, Spain, Sweden, Switzerland, 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 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.

Detailed Description

Condition or disease Intervention/treatment Phase

Bowel Dysfunction

Constipation

Drug: Placebo
Other Names
Drug: Alvimopan
Other Names
Entereg
Drug: Alviompan
Other Names
Entereg
Phase 3

Tracking Information

First Submitted DateNovember 29, 2005
Last Update Posted DateSeptember 01, 2015
Start DateAugust 01, 2005
Completion DateN/A
Primary Completion DateJune 01, 2006
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, pharmacogenetics (dependent on results from other data)

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleAlvimopan For The Treatment 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 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.

Detailed Description

Study TypeInterventional
Study PhasePhase 3
Estimated Enrollment
485
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: Placebo

Placebo

Other Names
Drug: Alvimopan

0.5 mg QD

Other Names
Entereg
Drug: Alviompan

0.5 mg BID

Other Names
Entereg
Study Groups/Cohorts
Placebo

Alvimopan 0.5 mg once daily
0.5 mg once daily (QD)

Alvimopan 0.5 mg twice daily
0.5 mg twice daily (BID)

Study Arms
Experimental Alvimopan 0.5 mg once daily
0.5 mg once daily (QD)
Drug : Alvimopan
0.5 mg QD

Experimental Alvimopan 0.5 mg twice daily
0.5 mg twice daily (BID)
Drug : Alviompan
0.5 mg BID

Placebo Comparator Placebo
Drug : Placebo
Placebo

Arm Intervention/Treatment
Experimental Alvimopan 0.5 mg once daily
0.5 mg once daily (QD)
Drug : Alvimopan
Experimental Alvimopan 0.5 mg twice daily
0.5 mg twice daily (BID)
Drug : Alviompan
Placebo Comparator Placebo
Drug : Placebo

Recruitment Information

Recruitment Status:Completed
Enrollment485
Completion DateN/A
Eligibility Criteria: 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.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Australia
Canada
France
Hungary
Netherlands
New Zealand
Norway
South Africa
Spain
Sweden
Switzerland
United States

Administrative Information

NCT Number:NCT00259922
Other Study ID Numbers
SB-767905/013
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