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 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)

518

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

  • Austria
      • Vienna, Austria, A-1100
        • GSK Investigational Site
      • Vienna, Austria, A-1130
        • GSK Investigational Site
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5A 4L8
        • GSK Investigational Site
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 2H4
        • GSK Investigational Site
      • Langley, British Columbia, Canada, V3A 4H9
        • GSK Investigational Site
    • Newfoundland and Labrador
      • Saint John's, Newfoundland and Labrador, Canada, A1B 3E1
        • GSK Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 5R3
        • GSK Investigational Site
    • Ontario
      • Brampton, Ontario, Canada, L6T 3J1
        • GSK Investigational Site
      • Kitchener, Ontario, Canada, N2M 5N6
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M9W 4L6
        • GSK Investigational Site
    • Quebec
      • Chandler, Quebec, Canada, G0C 1K0
        • GSK Investigational Site
      • Mirabel, Quebec, Canada, J7J 2K8
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H3M 3A9
        • GSK Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 1Z1
        • GSK Investigational Site
  • Denmark
      • Hvidovre, Denmark, 2650
        • GSK Investigational Site
      • Ishoj, Denmark, 2635
        • GSK Investigational Site
      • Odense C, Denmark, 5000
        • GSK Investigational Site
  • Estonia
      • Tallinn, Estonia, 10617
        • GSK Investigational Site
  • Finland
      • Helsinki, Finland, 00029
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 10117
        • GSK Investigational Site
      • Berlin, Germany, 10115
        • GSK Investigational Site
      • Berlin, Germany, 13125
        • GSK Investigational Site
      • Berlin, Germany, 10435
        • GSK Investigational Site
      • Berlin, Germany, 10409
        • GSK Investigational Site
      • Hamburg, Germany, 20249
        • GSK Investigational Site
      • Hamburg, Germany, 22525
        • GSK Investigational Site
      • Hamburg, Germany, 22149
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Fellbach, Baden-Wuerttemberg, Germany, 70736
        • GSK Investigational Site
      • Freiburg, Baden-Wuerttemberg, Germany, 79106
        • GSK Investigational Site
      • Villingen-Schwenningen, Baden-Wuerttemberg, Germany, 78054
        • GSK Investigational Site
      • Weinheim, Baden-Wuerttemberg, Germany, 69469
        • GSK Investigational Site
    • Bayern
      • Augsburg, Bayern, Germany, 86150
        • GSK Investigational Site
      • Nuernberg, Bayern, Germany, 90402
        • GSK Investigational Site
    • Hessen
      • Huettenberg, Hessen, Germany, 35625
        • GSK Investigational Site
      • Wiesbaden, Hessen, Germany, 65195
        • GSK Investigational Site
    • Mecklenburg-Vorpommern
      • Schwerin, Mecklenburg-Vorpommern, Germany, 19055
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45359
        • GSK Investigational Site
      • Koeln, Nordrhein-Westfalen, Germany, 51069
        • GSK Investigational Site
      • Koeln, Nordrhein-Westfalen, Germany, 50924
        • GSK Investigational Site
      • Viersen, Nordrhein-Westfalen, Germany, 41749
        • GSK Investigational Site
      • Witten, Nordrhein-Westfalen, Germany, 58455
        • GSK Investigational Site
    • Sachsen
      • Chemnitz, Sachsen, Germany, 09111
        • GSK Investigational Site
      • Dresden, Sachsen, Germany, 01307
        • GSK Investigational Site
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • GSK Investigational Site
      • Pinneberg, Schleswig-Holstein, Germany, 25421
        • GSK Investigational Site
  • Ireland
      • Cork, Ireland
        • GSK Investigational Site
  • Poland
      • Gdansk, Poland, 80-952
        • GSK Investigational Site
      • Krakow, Poland, 31-531
        • GSK Investigational Site
      • Wroclaw, Poland, 50-368
        • GSK Investigational Site
  • United Kingdom
      • Bexhill-on-Sea, East Sussex, United Kingdom, TN39 4SP
        • GSK Investigational Site
      • Leeds, United Kingdom, LS14 6UH
        • GSK Investigational Site
      • London, United Kingdom, SE5 9RS
        • GSK Investigational Site
      • Yaxley, Peterborough, United Kingdom, PE7 3JL
        • GSK Investigational Site
      • York, United Kingdom, YO31 8HE
        • GSK Investigational Site
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG7 3SQ
        • GSK Investigational Site
      • Slough, Berkshire, United Kingdom, SL2 1HD
        • GSK Investigational Site
    • Glamorgan
      • Cardiff, Glamorgan, United Kingdom, CF14 9BB
        • GSK Investigational Site
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G3 8YJ
        • GSK Investigational Site
      • Glasgow, Lanarkshire, United Kingdom, G69 7AD
        • GSK Investigational Site
    • Lancashire
      • Blackpool, Lancashire, United Kingdom, FY4 3AD
        • GSK Investigational Site
    • Middlesex
      • Ashford, Middlesex, United Kingdom, TW15 3EA
        • GSK Investigational Site
      • Sunbury-on-Thames, Middlesex, United Kingdom, TW16 6RH
        • GSK Investigational Site
    • Warwickshire
      • Coventry, Warwickshire, United Kingdom, CV6 4DD
        • GSK Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35244
        • GSK Investigational Site
      • Birmingham, Alabama, United States, 35243
        • GSK Investigational Site
      • Calera, Alabama, United States, 35040
        • GSK Investigational Site
      • Muscle Shoals, Alabama, United States, 35662
        • GSK Investigational Site
      • Tallassee, Alabama, United States, 36078
        • GSK Investigational Site
    • Arizona
      • Glendale, Arizona, United States, 85306
        • GSK Investigational Site
      • Phoenix, Arizona, United States, 85023
        • GSK Investigational Site
      • Phoenix, Arizona, United States, 85032
        • GSK Investigational Site
      • Sun City, Arizona, United States, 85351
        • GSK Investigational Site
      • Tucson, Arizona, United States, 85741
        • GSK Investigational Site
      • Tucson, Arizona, United States, 85711
        • GSK Investigational Site
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • GSK Investigational Site
      • Little Rock, Arkansas, United States, 72223
        • GSK Investigational Site
    • California
      • Anaheim, California, United States, 92801
        • GSK Investigational Site
      • Anaheim, California, United States, 92805
        • GSK Investigational Site
      • Beuna Park, California, United States, 90620
        • GSK Investigational Site
      • Burbank, California, United States, 91505
        • GSK Investigational Site
      • Duarte, California, United States, 91010
        • GSK Investigational Site
      • Fountain Valley, California, United States, 92708
        • GSK Investigational Site
      • Huntington Beach, California, United States, 92648
        • GSK Investigational Site
      • Mission Viejo, California, United States, 92691
        • GSK Investigational Site
      • Orange, California, United States, 92869
        • GSK Investigational Site
      • Redlands, California, United States, 92374
        • GSK Investigational Site
      • San Diego, California, United States, 92120
        • GSK Investigational Site
      • San Diego, California, United States, 92103-6204
        • GSK Investigational Site
      • San Diego, California, United States, 92121
        • GSK Investigational Site
      • Vista, California, United States, 92083
        • GSK Investigational Site
    • Connecticut
      • Waterbury, Connecticut, United States, 067708
        • GSK Investigational Site
    • Delaware
      • Newark, Delaware, United States, 19713
        • GSK Investigational Site
    • Florida
      • Brandon, Florida, United States, 33511
        • GSK Investigational Site
      • Brooksville, Florida, United States, 34613
        • GSK Investigational Site
      • Deland, Florida, United States, 32720
        • GSK Investigational Site
      • Fort Meyers, Florida, United States, 33907
        • GSK Investigational Site
      • Gainsville, Florida, United States, 32607
        • GSK Investigational Site
      • Hollywood, Florida, United States, 33021
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32256
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32257
        • GSK Investigational Site
      • Jupiter, Florida, United States, 33458
        • GSK Investigational Site
      • Largo, Florida, United States, 33773
        • GSK Investigational Site
      • Melbourne, Florida, United States, 32901
        • GSK Investigational Site
      • Miami, Florida, United States, 33186
        • GSK Investigational Site
      • Miami, Florida, United States, 33145
        • GSK Investigational Site
      • Niceville, Florida, United States, 32578
        • GSK Investigational Site
      • North Miami, Florida, United States, 33161
        • GSK Investigational Site
      • Ocala, Florida, United States, 32607
        • GSK Investigational Site
      • Orlando, Florida, United States, 32804
        • GSK Investigational Site
      • Ormond Beach, Florida, United States, 32174
        • GSK Investigational Site
      • Sarasota, Florida, United States, 34239
        • GSK Investigational Site
      • St. Petersburg, Florida, United States, 33703
        • GSK Investigational Site
      • Tampa, Florida, United States, 33603
        • GSK Investigational Site
      • West Palm Beach, Florida, United States, 33409
        • GSK Investigational Site
      • Winter Park, Florida, United States, 32789
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • GSK Investigational Site
      • Dawsonville, Georgia, United States, 30534
        • GSK Investigational Site
      • Decatur, Georgia, United States, 30033
        • GSK Investigational Site
      • Decatur, Georgia, United States, 30034
        • GSK Investigational Site
      • Marietta, Georgia, United States, 30066
        • GSK Investigational Site
    • Illinois
      • Bloomington, Illinois, United States, 61701
        • GSK Investigational Site
      • Rockford, Illinois, United States, 61107
        • GSK Investigational Site
    • Indiana
      • Elkhart, Indiana, United States, 46515
        • GSK Investigational Site
      • Evansville, Indiana, United States, 47714
        • GSK Investigational Site
      • Indianapolis, Indiana, United States, 46202
        • GSK Investigational Site
      • Indianapolis, Indiana, United States, 46250
        • GSK Investigational Site
      • Newburgh, Indiana, United States, 47630
        • GSK Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • GSK Investigational Site
      • Louisville, Kentucky, United States, 40213
        • GSK Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • GSK Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21229-5299
        • GSK Investigational Site
      • Elkridge, Maryland, United States, 21075
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • GSK Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • GSK Investigational Site
      • Portage, Michigan, United States, 49024
        • GSK Investigational Site
      • Saginaw, Michigan, United States, 48602
        • GSK Investigational Site
    • Minnesota
      • Chaska, Minnesota, United States, 55318
        • GSK Investigational Site
    • Mississippi
      • Picayune, Mississippi, United States, 39466
        • GSK Investigational Site
    • Missouri
      • Fenton, Missouri, United States, 63026
        • GSK Investigational Site
      • Manchester, Missouri, United States, 63021
        • GSK Investigational Site
      • St. Louis, Missouri, United States, 63141
        • GSK Investigational Site
      • St. Louis, Missouri, United States, 63128
        • GSK Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • GSK Investigational Site
    • Nevada
      • Incline Village, Nevada, United States, 89452
        • GSK Investigational Site
      • Las Vegas, Nevada, United States, 89119
        • GSK Investigational Site
      • Las Vegas, Nevada, United States, 89146
        • GSK Investigational Site
    • New Jersey
      • Elizabeth, New Jersey, United States, 07202
        • GSK Investigational Site
      • Haddon Heights, New Jersey, United States, 08035
        • GSK Investigational Site
      • Princeton, New Jersey, United States, 08540
        • GSK Investigational Site
    • New York
      • East Syracuse, New York, United States, 13057
        • GSK Investigational Site
      • New York, New York, United States, 10016
        • GSK Investigational Site
      • New York, New York, United States, 10010
        • GSK Investigational Site
      • Valley Stream, New York, United States, 11580
        • GSK Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • GSK Investigational Site
      • Charlotte, North Carolina, United States, 28204
        • GSK Investigational Site
      • Concord, North Carolina, United States, 28025
        • GSK Investigational Site
      • Greensboro, North Carolina, United States, 27401
        • GSK Investigational Site
      • Salisbury, North Carolina, United States, 28144
        • GSK Investigational Site
      • Wilmington, North Carolina, United States, 28412
        • GSK Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • GSK Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • GSK Investigational Site
      • Cincinnati, Ohio, United States, 45224
        • GSK Investigational Site
      • Columbus, Ohio, United States, 43215
        • GSK Investigational Site
      • Dayton, Ohio, United States, 45408
        • GSK Investigational Site
      • Dayton, Ohio, United States, 45439
        • GSK Investigational Site
      • Maumee, Ohio, United States, 43537
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • GSK Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97404
        • GSK Investigational Site
      • Medford, Oregon, United States, 97504
        • GSK Investigational Site
      • Oregon City, Oregon, United States, 97045
        • GSK Investigational Site
      • Portland, Oregon, United States, 97225
        • GSK Investigational Site
      • Portland, Oregon, United States, 97210
        • GSK Investigational Site
      • Portland, Oregon, United States, 97232
        • GSK Investigational Site
    • Pennsylvania
      • Bala Cynwyd, Pennsylvania, United States, 19004
        • GSK Investigational Site
      • Nazareth, Pennsylvania, United States, 18064
        • GSK Investigational Site
      • Whitehall, Pennsylvania, United States, 18052
        • GSK Investigational Site
      • Wyomissing, Pennsylvania, United States, 19610
        • GSK Investigational Site
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • GSK Investigational Site
      • Woonsocket, Rhode Island, United States, 02895
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • GSK Investigational Site
      • Murrells Inlet, South Carolina, United States, 29576
        • GSK Investigational Site
      • Spartanburg, South Carolina, United States, 29303
        • GSK Investigational Site
    • Texas
      • Arlington, Texas, United States, 76017
        • GSK Investigational Site
      • Brownwood, Texas, United States, 76801
        • GSK Investigational Site
      • Colleyville, Texas, United States, 76034
        • GSK Investigational Site
      • Galveston, Texas, United States, 77555
        • GSK Investigational Site
      • Houston, Texas, United States, 77074
        • GSK Investigational Site
      • Houston, Texas, United States, 77054
        • GSK Investigational Site
      • Lake Jackson, Texas, United States, 77566
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78205
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78238
        • GSK Investigational Site
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • GSK Investigational Site
      • Chesapeake, Virginia, United States, 23322
        • GSK Investigational Site
      • Christiansburg, Virginia, United States, 24073
        • GSK Investigational Site
      • Danville, Virginia, United States, 24541
        • GSK Investigational Site
      • Virginia Beach, Virginia, United States, 23452
        • GSK Investigational Site
    • Washington
      • Bellingham, Washington, United States, 98226
        • GSK Investigational Site
      • Edmonds, Washington, United States, 98026
        • GSK Investigational Site
      • Lacey, Washington, United States, 98516
        • GSK Investigational Site
      • Spokane, Washington, United States, 99204
        • 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:

  • 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.

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
Experimental: Alvimopan 0.5 mg once daily
Drug: alvimopan
0.5 mg
Other Names:
  • Entereg
Experimental: alvimopan 0.5 mg twice daily
Drug: alvimopan
0.5 mg
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, pharmacokinetics, 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

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

November 21, 2005

First Submitted That Met QC Criteria

November 21, 2005

First Posted (Estimate)

November 22, 2005

Study Record Updates

Last Update Posted (Estimate)

September 2, 2015

Last Update Submitted That Met QC Criteria

September 1, 2015

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SB-767905/012

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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