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

September 1, 2015 updated by: Cubist Pharmaceuticals LLC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

485

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Broadmeadow, New South Wales, Australia, 2292
        • GSK Investigational Site
      • Newcastle, New South Wales, Australia, 2300
        • GSK Investigational Site
      • St Leonards, New South Wales, Australia, 2065
        • GSK Investigational Site
    • Queensland
      • Carina Heights, Queensland, Australia, 4152
        • GSK Investigational Site
      • Kippa Ring, Queensland, Australia, 4021
        • GSK Investigational Site
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • GSK Investigational Site
      • Port Lincoln, South Australia, Australia, 5606
        • GSK Investigational Site
      • Toorak Gardens, South Australia, Australia, 5065
        • GSK Investigational Site
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • GSK Investigational Site
      • Carlton, Victoria, Australia, 3053
        • GSK Investigational Site
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • GSK Investigational Site
      • Nedlands, Western Australia, Australia, 6009
        • GSK Investigational Site
  • Canada
    • British Columbia
      • Coquitlam, British Columbia, Canada, V3K 3V9
        • GSK Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • GSK Investigational Site
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1G 1A7
        • GSK Investigational Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1E 2C2
        • GSK Investigational Site
    • Ontario
      • Mississauga, Ontario, Canada, L4T 4J2
        • GSK Investigational Site
      • North Bay, Ontario, Canada, P1B 2H3
        • GSK Investigational Site
      • North York, Ontario, Canada, M2M 4E7
        • GSK Investigational Site
      • Sudbury, Ontario, Canada, P3A 1Y8
        • GSK Investigational Site
    • Quebec
      • Bonaventure, Quebec, Canada, G0C 1E0
        • GSK Investigational Site
      • Saint Romuald, Quebec, Canada, G6W 5M6
        • GSK Investigational Site
      • Trois-Rivieres, Quebec, Canada, G8Z 1Y2
        • GSK Investigational Site
  • France
      • Boulogne, France, 92100
        • GSK Investigational Site
      • Grenoble, France, 38000
        • GSK Investigational Site
      • Montpellier Cedex 5, France, 34295
        • GSK Investigational Site
      • Paris, France, 75012
        • GSK Investigational Site
      • Paris, France, 75010
        • GSK Investigational Site
      • Paris Cedex 4, France, 75181
        • GSK Investigational Site
  • Hungary
      • Budapest, Hungary, 1083
        • GSK Investigational Site
      • Budapest, Hungary, 1183
        • GSK Investigational Site
      • Csongrád, Hungary, 6640
        • GSK Investigational Site
      • Heves, Hungary, 3360
        • GSK Investigational Site
  • Netherlands
      • Alkmaar, Netherlands, 1815 JD
        • GSK Investigational Site
      • Breda, Netherlands, 4819 EV
        • GSK Investigational Site
      • Roosendaal, Netherlands, 4708 AE
        • GSK Investigational Site
      • Rotterdam, Netherlands, 3083 AN
        • GSK Investigational Site
      • Utrecht, Netherlands, 3584 CX
        • GSK Investigational Site
  • New Zealand
      • Christchurch, New Zealand
        • GSK Investigational Site
      • Hamilton, New Zealand, 2001
        • GSK Investigational Site
      • Tauranga, New Zealand, 3001
        • GSK Investigational Site
  • Norway
      • Oslo, Norway, N-0027
        • GSK Investigational Site
      • Oslo, Norway, N-0260
        • GSK Investigational Site
      • Paradis, Norway, 5231
        • GSK Investigational Site
      • Rådahl, Norway, 5235
        • GSK Investigational Site
      • Skien, Norway, N-3710
        • GSK Investigational Site
  • South Africa
      • Athlone, Cape Town, South Africa, 7760
        • GSK Investigational Site
      • Erasmuskloof, Pretoria, South Africa, 0048
        • GSK Investigational Site
      • Fourways, Johannesburg, South Africa
        • GSK Investigational Site
      • Kempton Park, South Africa, 1620
        • GSK Investigational Site
      • Kenilworth, Cape Town, South Africa, 7708
        • GSK Investigational Site
      • Lynnwood, Pretoria, South Africa, 0040
        • GSK Investigational Site
      • Tygervalley, South Africa, 7536
        • GSK Investigational Site
      • Westridge, Mitchells Plain, South Africa, 7798
        • GSK Investigational Site
  • Spain
      • Alcorcon, Spain, 28922
        • GSK Investigational Site
      • Barcelona, Spain, 08003
        • GSK Investigational Site
      • El Ferrol, Spain
        • GSK Investigational Site
      • Granada, Spain, 18012
        • GSK Investigational Site
      • Madrid, Spain, 28006
        • GSK Investigational Site
      • Madrid, Spain, 28034
        • GSK Investigational Site
      • Santander, Spain, 39008
        • GSK Investigational Site
      • Valencia, Spain, 46014
        • GSK Investigational Site
  • Sweden
      • Jönköping, Sweden, SE-551 85
        • GSK Investigational Site
      • Karlstad, Sweden, SE-651 85
        • GSK Investigational Site
      • Linköping, Sweden, SE-581 85
        • GSK Investigational Site
      • Stockholm, Sweden, SE-141 86
        • GSK Investigational Site
  • Switzerland
      • Bern, Switzerland, 3011
        • GSK Investigational Site
      • Nottwil, Switzerland, 6207
        • GSK Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35215
        • GSK Investigational Site
      • Birmingham, Alabama, United States, 35216
        • GSK Investigational Site
      • Huntsville, Alabama, United States, 35801
        • GSK Investigational Site
      • Mobile, Alabama, United States, 36606
        • GSK Investigational Site
      • Northport, Alabama, United States, 35476
        • GSK Investigational Site
    • Arizona
      • Mesa, Arizona, United States, 85205
        • GSK Investigational Site
      • Phoenix, Arizona, United States, 85029
        • GSK Investigational Site
      • Scottsdale, Arizona, United States, 85258
        • GSK Investigational Site
      • Scottsdale, Arizona, United States, 85251
        • GSK Investigational Site
      • Tempe, Arizona, United States, 85282
        • GSK Investigational Site
      • Tucson, Arizona, United States, 85712
        • GSK Investigational Site
      • Tucson, Arizona, United States, 85724
        • GSK Investigational Site
    • California
      • Bakersfield, California, United States, 93311
        • GSK Investigational Site
      • Beverly Hills, California, United States, 90211
        • GSK Investigational Site
      • Long Beach, California, United States, 90813
        • GSK Investigational Site
      • Los Angeles, California, United States, 90048
        • GSK Investigational Site
      • Los Gatos, California, United States, 95032
        • GSK Investigational Site
      • Northridge, California, United States, 91325
        • GSK Investigational Site
      • Orange, California, United States, 92868
        • GSK Investigational Site
      • Palm Springs, California, United States, 92262
        • GSK Investigational Site
      • Pasadena, California, United States, 91105
        • GSK Investigational Site
      • Sacramento, California, United States, 95816
        • GSK Investigational Site
      • San Diego, California, United States, 92108
        • GSK Investigational Site
      • San Rafael, California, United States, 94901
        • GSK Investigational Site
      • Santa Ana, California, United States, 92704
        • GSK Investigational Site
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • GSK Investigational Site
      • Waterbury, Connecticut, United States, 06708
        • GSK Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20003
        • GSK Investigational Site
    • Florida
      • Chiefland, Florida, United States, 32626
        • GSK Investigational Site
      • Clearwater, Florida, United States, 33761
        • GSK Investigational Site
      • Deerfield Beach, Florida, United States, 33441
        • GSK Investigational Site
      • Destin, Florida, United States, 32541
        • GSK Investigational Site
      • Fort Myers, Florida, United States, 33916
        • GSK Investigational Site
      • Hollywood, Florida, United States, 33021
        • GSK Investigational Site
      • Hollywood, Florida, United States, 33023
        • GSK Investigational Site
      • Largo, Florida, United States, 33770
        • GSK Investigational Site
      • Margate, Florida, United States, 33063
        • GSK Investigational Site
      • Miami, Florida, United States, 33169
        • GSK Investigational Site
      • Miami, Florida, United States, 33155
        • GSK Investigational Site
      • Miami, Florida, United States, 33138
        • GSK Investigational Site
      • Ocala, Florida, United States, 34471
        • GSK Investigational Site
      • Ormond Beach, Florida, United States, 32174
        • GSK Investigational Site
      • St. Cloud, Florida, United States, 34769
        • GSK Investigational Site
      • Tampa, Florida, United States, 33614
        • GSK Investigational Site
      • West Palm Beach, Florida, United States, 33401
        • GSK Investigational Site
      • Winterhaven, Florida, United States, 33880
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • GSK Investigational Site
      • Atlanta, Georgia, United States, 30338
        • GSK Investigational Site
      • Cumming, Georgia, United States, 30040
        • GSK Investigational Site
      • Marietta, Georgia, United States, 30066
        • GSK Investigational Site
      • Stockbridge, Georgia, United States, 30281
        • GSK Investigational Site
    • Idaho
      • Meridian, Idaho, United States, 83642
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60610
        • GSK Investigational Site
      • Libertyville, Illinois, United States, 60048
        • GSK Investigational Site
      • Oak Forest, Illinois, United States, 60452
        • GSK Investigational Site
      • Oakbrook Terrace, Illinois, United States, 60181
        • GSK Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47714
        • GSK Investigational Site
      • Indianapolis, Indiana, United States, 46250
        • GSK Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • GSK Investigational Site
      • Louisville, Kentucky, United States, 40205
        • GSK Investigational Site
    • Louisiana
      • Sunset, Louisiana, United States, 70584
        • GSK Investigational Site
    • Maryland
      • Pasadena, Maryland, United States, 21122
        • GSK Investigational Site
      • Rockville, Maryland, United States, 20852
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • GSK Investigational Site
      • Brockton, Massachusetts, United States, 02301
        • GSK Investigational Site
      • Wellesley Hills, Massachusetts, United States, 02481
        • GSK Investigational Site
    • Michigan
      • Portage, Michigan, United States, 49024
        • GSK Investigational Site
      • Waterford, Michigan, United States, 48327
        • GSK Investigational Site
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654
        • GSK Investigational Site
    • Missouri
      • Independence, Missouri, United States, 64055
        • GSK Investigational Site
      • St. Louis, Missouri, United States, 63141
        • GSK Investigational Site
      • St. Louis, Missouri, United States, 63108
        • GSK Investigational Site
    • Montana
      • Missoula, Montana, United States, 59804
        • GSK Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • GSK Investigational Site
      • Las Vegas, Nevada, United States, 89102
        • GSK Investigational Site
      • Las Vegas, Nevada, United States, 89103
        • GSK Investigational Site
      • Las Vegas, Nevada, United States, 89146
        • GSK Investigational Site
    • New Hampshire
      • Dover, New Hampshire, United States, 03820
        • GSK Investigational Site
    • New Jersey
      • Blackwood, New Jersey, United States, 08012
        • GSK Investigational Site
      • Egg Harbor Township, New Jersey, United States, 08234
        • GSK Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • GSK Investigational Site
    • New York
      • Mineola, New York, United States, 11501
        • GSK Investigational Site
      • New York, New York, United States, 10022
        • GSK Investigational Site
      • Rochester, New York, United States, 14627
        • GSK Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • GSK Investigational Site
      • Greensboro, North Carolina, United States, 27403
        • GSK Investigational Site
      • Hickory, North Carolina, United States, 28601
        • GSK Investigational Site
      • Raleigh, North Carolina, United States, 27607
        • GSK Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • GSK Investigational Site
    • Ohio
      • Centerville, Ohio, United States, 45450
        • GSK Investigational Site
      • Cincinnati, Ohio, United States, 45236
        • GSK Investigational Site
      • Dayton, Ohio, United States, 46432
        • GSK Investigational Site
      • Perrysburg, Ohio, United States, 43551
        • GSK Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • GSK Investigational Site
      • Medford, Oregon, United States, 97504
        • GSK Investigational Site
      • Portland, Oregon, United States, 97210
        • GSK Investigational Site
      • Salem, Oregon, United States, 97301
        • GSK Investigational Site
    • Pennsylvania
      • Levittown, Pennsylvania, United States, 19056
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15243
        • GSK Investigational Site
      • Reading, Pennsylvania, United States, 19611
        • GSK Investigational Site
    • Rhode Island
      • Cranston, Rhode Island, United States, 02920
        • GSK Investigational Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • GSK Investigational Site
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • GSK Investigational Site
      • New Tazewell, Tennessee, United States, 37824-1409
        • GSK Investigational Site
    • Texas
      • Austin, Texas, United States, 78756
        • GSK Investigational Site
      • Corpus Christi, Texas, United States, 78404
        • GSK Investigational Site
      • Galveston, Texas, United States, 77555-0188
        • GSK Investigational Site
      • Houston, Texas, United States, 77070
        • GSK Investigational Site
      • Richardson, Texas, United States, 75080
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78229
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78217
        • GSK Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • GSK Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • GSK Investigational Site
      • Richmond, Virginia, United States, 23294
        • GSK Investigational Site
    • Washington
      • Spokane, Washington, United States, 99207
        • GSK Investigational Site
      • Tacoma, Washington, United States, 98405
        • GSK Investigational Site
      • Yakima, Washington, United States, 98902
        • GSK Investigational Site
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • GSK Investigational Site
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Experimental: Alvimopan 0.5 mg once daily
0.5 mg once daily (QD)
Drug: Alvimopan
0.5 mg QD
Other Names:
  • Entereg
Experimental: Alvimopan 0.5 mg twice daily
0.5 mg twice daily (BID)
Drug: Alviompan
0.5 mg BID
Other Names:
  • Entereg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To compare alvimopan with placebo for efficacy in the treatment of OBD

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cubist Pharmaceuticals LLC

Collaborators

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

November 29, 2005

First Submitted That Met QC Criteria

November 29, 2005

First Posted (Estimate)

December 1, 2005

Study Record Updates

Last Update Posted (Estimate)

September 2, 2015

Last Update Submitted That Met QC Criteria

September 1, 2015

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SB-767905/013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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