Long-Term Safety Evaluation Of Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain

August 29, 2017 updated by: Cubist Pharmaceuticals LLC

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate Long-Term Safety and Efficacy of Alvimopan 0.5mg Twice Daily for 12 Months 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) to alvimopan or placebo. The primary objective of this Phase 3 long-term safety study is to compare alvimopan with placebo for safety and tolerability in the treatment of OBD. Participants will be required to attend 8 clinic visits over approximately 1 year.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

805

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
      • 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
  • Austria
      • Vienna, Austria, A-1100
        • GSK Investigational Site
      • Vienna, Austria, A-1130
        • GSK Investigational Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3C 3P1
        • GSK Investigational Site
      • Edmonton, Alberta, Canada, T5A 4L8
        • GSK Investigational Site
    • British Columbia
      • Coquitlam, British Columbia, Canada, V3K 3P4
        • GSK Investigational Site
      • Kelowna, British Columbia, Canada, V1Y 2H4
        • GSK Investigational Site
      • Langley, British Columbia, Canada, V3A 4H9
        • 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
      • Saint John's, Newfoundland and Labrador, Canada, A1E 2C2
        • GSK Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 5R3
        • GSK Investigational Site
    • Ontario
      • Brampton, Ontario, Canada, L6T 3J1
        • GSK Investigational Site
      • Hamilton, Ontario, Canada, L8L 5G8
        • GSK Investigational Site
      • Kitchener, Ontario, Canada, N2M 5N6
        • GSK Investigational Site
      • 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, P3E 1H5
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M9W 4L6
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M3H 5S4
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M3J 1N2
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M3N 2V7
        • GSK Investigational Site
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada, C1A 8T5
        • GSK Investigational Site
    • Quebec
      • Bonaventure, Quebec, Canada, G0C 1E0
        • GSK Investigational Site
      • Chandler, Quebec, Canada, G0C 1K0
        • GSK Investigational Site
      • Drummondville, Quebec, Canada, J2B 1H8
        • GSK Investigational Site
      • Mirabel, Quebec, Canada, J7J 2K8
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H3M 3A9
        • GSK Investigational Site
      • Saint Romuald, Quebec, Canada, G6W 5M6
        • GSK Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 1Z1
        • GSK Investigational Site
      • Trois-Rivieres, Quebec, Canada, G8Z 1Y2
        • GSK Investigational Site
  • Denmark
      • Ishoj, Denmark, 2635
        • GSK Investigational Site
  • Finland
      • Helsinki, Finland, 00029
        • GSK Investigational Site
  • Hong Kong
      • Kowloon, Hong Kong
        • GSK Investigational Site
      • Kwun Tong, Hong Kong
        • GSK Investigational Site
      • Pokfulam, Hong Kong
        • GSK Investigational Site
      • Shatin, Hong Kong
        • GSK Investigational Site
  • Hungary
      • Budapest, Hungary, 1083
        • GSK Investigational Site
  • Ireland
      • Cork, Ireland
        • GSK Investigational Site
  • Netherlands
      • Roosendaal, Netherlands, 4708 AE
        • 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
  • Poland
      • Gdansk, Poland, 80-952
        • GSK Investigational Site
      • Krakow, Poland, 31-531
        • GSK Investigational Site
      • Wroclaw, Poland, 50-368
        • 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
  • Taiwan
      • Tainan, Taiwan, 704
        • GSK Investigational Site
      • Taipei, Taiwan, 100
        • GSK Investigational Site
      • Taipei, Taiwan, 114
        • 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, EC1A 7BE
        • GSK Investigational Site
      • Yaxley, Peterborough, United Kingdom, PE7 3JL
        • 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
    • Middlesex
      • 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, 35215
        • GSK Investigational Site
      • Birmingham, Alabama, United States, 35242
        • GSK Investigational Site
      • Huntsville, Alabama, United States, 35801
        • GSK Investigational Site
      • Mobile, Alabama, United States, 36606
        • GSK Investigational Site
      • Muscle Shoals, Alabama, United States, 35662
        • GSK Investigational Site
      • Northport, Alabama, United States, 35476
        • 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
      • Phoenix, Arizona, United States, 85029
        • GSK Investigational Site
      • Scottsdale, Arizona, United States, 85258
        • GSK Investigational Site
      • Scottsdale, Arizona, United States, 85251
        • GSK Investigational Site
      • Sun City, Arizona, United States, 85351
        • GSK Investigational Site
      • Tempe, Arizona, United States, 85282
        • GSK Investigational Site
      • Tucson, Arizona, United States, 85712
        • GSK Investigational Site
      • Tucson, Arizona, United States, 85741
        • 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
      • Bakersfield, California, United States, 93311
        • GSK Investigational Site
      • Beverly Hills, California, United States, 90211
        • GSK Investigational Site
      • Buena Park, California, United States, 90620
        • GSK Investigational Site
      • Burbank, California, United States, 91505
        • GSK Investigational Site
      • Los Gatos, California, United States, 95032
        • GSK Investigational Site
      • Orange, California, United States, 92868
        • GSK Investigational Site
      • Palm Springs, California, United States, 92262
        • GSK Investigational Site
      • Pismo Beach, California, United States, 93449
        • GSK Investigational Site
      • San Diego, California, United States, 92120
        • GSK Investigational Site
      • San Diego, California, United States, 92108
        • GSK Investigational Site
      • San Diego, California, United States, 92121
        • GSK Investigational Site
      • Torrance, California, United States, 90503
        • GSK Investigational Site
      • Vista, California, United States, 92083
        • GSK Investigational Site
    • Connecticut
      • Stratford, Connecticut, United States, 6497
        • GSK Investigational Site
      • Trumbull, Connecticut, United States, 06611
        • GSK Investigational Site
    • Florida
      • Brandon, Florida, United States, 33511
        • GSK Investigational Site
      • Chiefland, Florida, United States, 32626
        • GSK Investigational Site
      • Clearwater, Florida, United States, 33756
        • GSK Investigational Site
      • Clearwater, Florida, United States, 33765
        • GSK Investigational Site
      • DeLand, Florida, United States, 32720
        • GSK Investigational Site
      • Deerfield Beach, Florida, United States, 33441
        • GSK Investigational Site
      • Fort Myers, Florida, United States, 33907
        • GSK Investigational Site
      • Gainesville, Florida, United States, 32607
        • GSK Investigational Site
      • Holly Hill, Florida, United States, 32117
        • GSK Investigational Site
      • Hollywood, Florida, United States, 33021
        • GSK Investigational Site
      • Jupiter, Florida, United States, 33458
        • GSK Investigational Site
      • Miami, Florida, United States, 33169
        • GSK Investigational Site
      • Ocala, Florida, United States, 34471
        • 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
      • Saint Cloud, Florida, United States, 34769
        • GSK Investigational Site
      • West Palm Beach, Florida, United States, 33409
        • GSK Investigational Site
    • Georgia
      • Dawsonville, Georgia, United States, 30534
        • GSK Investigational Site
      • Marietta, Georgia, United States, 30066
        • GSK Investigational Site
      • Stockbridge, Georgia, United States, 30281
        • GSK Investigational Site
      • Suwanee, Georgia, United States, 30024
        • GSK Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83702
        • GSK Investigational Site
      • Meridian, Idaho, United States, 83642
        • GSK Investigational Site
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • GSK Investigational Site
      • Bloomington, Illinois, United States, 61701
        • GSK Investigational Site
      • Chicago, Illinois, United States, 60610
        • GSK Investigational Site
      • Rockford, Illinois, United States, 61107
        • GSK Investigational Site
    • Indiana
      • Elkhart, Indiana, United States, 46515
        • GSK Investigational Site
      • Indianapolis, Indiana, United States, 46250
        • GSK Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • GSK Investigational Site
      • Louisville, Kentucky, United States, 40205
        • GSK Investigational Site
      • Madisonville, Kentucky, United States, 42431
        • GSK Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • GSK Investigational Site
      • Shreveport, Louisiana, United States, 71103
        • 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
      • Detroit, Michigan, United States, 48202
        • GSK Investigational Site
      • Grand Blanc, Michigan, United States, 48439
        • GSK Investigational Site
      • Portage, Michigan, United States, 49024
        • GSK Investigational Site
      • Traverse City, Michigan, United States, 49684
        • GSK Investigational Site
    • Minnesota
      • Chaska, Minnesota, United States, 55318
        • GSK Investigational Site
    • Mississippi
      • Olive Branch, Mississippi, United States, 38654
        • GSK Investigational Site
    • Missouri
      • Manchester, Missouri, United States, 63021
        • GSK Investigational Site
      • Nixa, Missouri, United States, 65714
        • GSK Investigational Site
      • Saint Louis, Missouri, United States, 63108
        • GSK Investigational Site
    • Montana
      • Missoula, Montana, United States, 59804
        • GSK Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • GSK Investigational Site
    • Nevada
      • Henderson, Nevada, United States, 89015
        • GSK Investigational Site
      • 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
    • New Hampshire
      • Dover, New Hampshire, United States, 03820
        • GSK Investigational Site
    • New Jersey
      • Blackwood, New Jersey, United States, 08012
        • GSK Investigational Site
      • Elizabeth, New Jersey, United States, 07202
        • GSK Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • GSK Investigational Site
    • New York
      • Lake Success, New York, United States, 11042
        • GSK Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • 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, 27403
        • GSK Investigational Site
      • Greensboro, North Carolina, United States, 27401
        • 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, 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
      • Dayton, Ohio, United States, 46432
        • GSK Investigational Site
    • Oklahoma
      • Clinton, Oklahoma, United States, 73601
        • GSK Investigational Site
      • Oklahoma City, Oklahoma, United States, 73112
        • GSK Investigational Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • GSK Investigational Site
      • Oregon City, Oregon, United States, 97045
        • GSK Investigational Site
      • Portland, Oregon, United States, 97210
        • GSK Investigational Site
    • Pennsylvania
      • Carnegie, Pennsylvania, United States, 15106
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15243
        • GSK Investigational Site
      • Reading, Pennsylvania, United States, 19611
        • GSK Investigational Site
    • Rhode Island
      • Woonsocket, Rhode Island, United States, 02895
        • GSK Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • GSK Investigational Site
      • Clarksville, Tennessee, United States, 37043
        • GSK Investigational Site
      • Kingsport, Tennessee, United States, 37660
        • GSK Investigational Site
    • Texas
      • Arlington, Texas, United States, 76017
        • GSK Investigational Site
      • Brownwood, Texas, United States, 76801
        • GSK Investigational Site
      • Dallas, Texas, United States, 75218
        • GSK Investigational Site
      • Grand Prairie, Texas, United States, 75052
        • GSK Investigational Site
      • Houston, Texas, United States, 77074
        • GSK Investigational Site
      • Houston, Texas, United States, 77090
        • GSK Investigational Site
      • Lake Jackson, Texas, United States, 77566
        • GSK Investigational Site
      • Lancaster, Texas, United States, 75146
        • GSK Investigational Site
      • Richardson, Texas, United States, 75080
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78238
        • GSK Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84120
        • GSK Investigational Site
      • Salt Lake City, Utah, United States, 84106
        • GSK Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • GSK Investigational Site
      • Richmond, Virginia, United States, 23294
        • 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
      • Spokane, Washington, United States, 99204
        • GSK Investigational Site
      • Tacoma, Washington, United States, 98405
        • GSK Investigational Site
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • 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).

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.
  • Human Immunodeficiency Virus (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
Experimental: Alvimopan 0.5 mg Twice Daily (BID)
0.5 milligrams (mg) of alvimopan was administered orally twice daily (BID) for 12 months.
Drug: Alvimopan
Placebo Comparator: Placebo
Placebo was administered orally BID for 12 months.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To compare alvimopan with placebo for long-term safety and tolerability
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life, pharmacokinetics, pharmacogenetics (dependent on results from other data)
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Cubist Pharmaceuticals LLC

Collaborators

GlaxoSmithKline

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 (Actual)

August 1, 2005

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

October 17, 2005

First Submitted That Met QC Criteria

October 17, 2005

First Posted (Estimate)

October 19, 2005

Study Record Updates

Last Update Posted (Actual)

August 30, 2017

Last Update Submitted That Met QC Criteria

August 29, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3753-013
  • SB-767905/014 (Other Identifier: Cubist Study Number)

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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