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Spots Global Cancer Trial Database for Alvimopan For The Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain

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Trial Identification

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

Official Title: 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

Study ID: NCT00259922

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:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

GSK Investigational Site, Birmingham, Alabama, United States

GSK Investigational Site, Birmingham, Alabama, United States

GSK Investigational Site, Huntsville, Alabama, United States

GSK Investigational Site, Mobile, Alabama, United States

GSK Investigational Site, Northport, Alabama, United States

GSK Investigational Site, Mesa, Arizona, United States

GSK Investigational Site, Phoenix, Arizona, United States

GSK Investigational Site, Scottsdale, Arizona, United States

GSK Investigational Site, Scottsdale, Arizona, United States

GSK Investigational Site, Tempe, Arizona, United States

GSK Investigational Site, Tucson, Arizona, United States

GSK Investigational Site, Tucson, Arizona, United States

GSK Investigational Site, Bakersfield, California, United States

GSK Investigational Site, Beverly Hills, California, United States

GSK Investigational Site, Long Beach, California, United States

GSK Investigational Site, Los Angeles, California, United States

GSK Investigational Site, Los Gatos, California, United States

GSK Investigational Site, Northridge, California, United States

GSK Investigational Site, Orange, California, United States

GSK Investigational Site, Palm Springs, California, United States

GSK Investigational Site, Pasadena, California, United States

GSK Investigational Site, Sacramento, California, United States

GSK Investigational Site, San Diego, California, United States

GSK Investigational Site, San Rafael, California, United States

GSK Investigational Site, Santa Ana, California, United States

GSK Investigational Site, Stamford, Connecticut, United States

GSK Investigational Site, Waterbury, Connecticut, United States

GSK Investigational Site, Washington, District of Columbia, United States

GSK Investigational Site, Chiefland, Florida, United States

GSK Investigational Site, Clearwater, Florida, United States

GSK Investigational Site, Deerfield Beach, Florida, United States

GSK Investigational Site, Destin, Florida, United States

GSK Investigational Site, Fort Myers, Florida, United States

GSK Investigational Site, Hollywood, Florida, United States

GSK Investigational Site, Hollywood, Florida, United States

GSK Investigational Site, Largo, Florida, United States

GSK Investigational Site, Margate, Florida, United States

GSK Investigational Site, Miami, Florida, United States

GSK Investigational Site, Miami, Florida, United States

GSK Investigational Site, Miami, Florida, United States

GSK Investigational Site, Ocala, Florida, United States

GSK Investigational Site, Ormond Beach, Florida, United States

GSK Investigational Site, St. Cloud, Florida, United States

GSK Investigational Site, Tampa, Florida, United States

GSK Investigational Site, West Palm Beach, Florida, United States

GSK Investigational Site, Winterhaven, Florida, United States

GSK Investigational Site, Atlanta, Georgia, United States

GSK Investigational Site, Atlanta, Georgia, United States

GSK Investigational Site, Cumming, Georgia, United States

GSK Investigational Site, Marietta, Georgia, United States

GSK Investigational Site, Stockbridge, Georgia, United States

GSK Investigational Site, Meridian, Idaho, United States

GSK Investigational Site, Chicago, Illinois, United States

GSK Investigational Site, Libertyville, Illinois, United States

GSK Investigational Site, Oak Forest, Illinois, United States

GSK Investigational Site, Oakbrook Terrace, Illinois, United States

GSK Investigational Site, Evansville, Indiana, United States

GSK Investigational Site, Indianapolis, Indiana, United States

GSK Investigational Site, Lexington, Kentucky, United States

GSK Investigational Site, Louisville, Kentucky, United States

GSK Investigational Site, Sunset, Louisiana, United States

GSK Investigational Site, Pasadena, Maryland, United States

GSK Investigational Site, Rockville, Maryland, United States

GSK Investigational Site, Boston, Massachusetts, United States

GSK Investigational Site, Brockton, Massachusetts, United States

GSK Investigational Site, Wellesley Hills, Massachusetts, United States

GSK Investigational Site, Portage, Michigan, United States

GSK Investigational Site, Waterford, Michigan, United States

GSK Investigational Site, Olive Branch, Mississippi, United States

GSK Investigational Site, Independence, Missouri, United States

GSK Investigational Site, St. Louis, Missouri, United States

GSK Investigational Site, St. Louis, Missouri, United States

GSK Investigational Site, Missoula, Montana, United States

GSK Investigational Site, Las Vegas, Nevada, United States

GSK Investigational Site, Las Vegas, Nevada, United States

GSK Investigational Site, Las Vegas, Nevada, United States

GSK Investigational Site, Las Vegas, Nevada, United States

GSK Investigational Site, Dover, New Hampshire, United States

GSK Investigational Site, Blackwood, New Jersey, United States

GSK Investigational Site, Egg Harbor Township, New Jersey, United States

GSK Investigational Site, Albuquerque, New Mexico, United States

GSK Investigational Site, Mineola, New York, United States

GSK Investigational Site, New York, New York, United States

GSK Investigational Site, Rochester, New York, United States

GSK Investigational Site, Asheville, North Carolina, United States

GSK Investigational Site, Greensboro, North Carolina, United States

GSK Investigational Site, Hickory, North Carolina, United States

GSK Investigational Site, Raleigh, North Carolina, United States

GSK Investigational Site, Winston-Salem, North Carolina, United States

GSK Investigational Site, Centerville, Ohio, United States

GSK Investigational Site, Cincinnati, Ohio, United States

GSK Investigational Site, Dayton, Ohio, United States

GSK Investigational Site, Perrysburg, Ohio, United States

GSK Investigational Site, Eugene, Oregon, United States

GSK Investigational Site, Medford, Oregon, United States

GSK Investigational Site, Portland, Oregon, United States

GSK Investigational Site, Salem, Oregon, United States

GSK Investigational Site, Levittown, Pennsylvania, United States

GSK Investigational Site, Pittsburgh, Pennsylvania, United States

GSK Investigational Site, Reading, Pennsylvania, United States

GSK Investigational Site, Cranston, Rhode Island, United States

GSK Investigational Site, Greer, South Carolina, United States

GSK Investigational Site, Kingsport, Tennessee, United States

GSK Investigational Site, New Tazewell, Tennessee, United States

GSK Investigational Site, Austin, Texas, United States

GSK Investigational Site, Corpus Christi, Texas, United States

GSK Investigational Site, Galveston, Texas, United States

GSK Investigational Site, Houston, Texas, United States

GSK Investigational Site, Richardson, Texas, United States

GSK Investigational Site, San Antonio, Texas, United States

GSK Investigational Site, San Antonio, Texas, United States

GSK Investigational Site, Salt Lake City, Utah, United States

GSK Investigational Site, Norfolk, Virginia, United States

GSK Investigational Site, Richmond, Virginia, United States

GSK Investigational Site, Spokane, Washington, United States

GSK Investigational Site, Tacoma, Washington, United States

GSK Investigational Site, Yakima, Washington, United States

GSK Investigational Site, Charleston, West Virginia, United States

GSK Investigational Site, La Crosse, Wisconsin, United States

GSK Investigational Site, Broadmeadow, New South Wales, Australia

GSK Investigational Site, Newcastle, New South Wales, Australia

GSK Investigational Site, St Leonards, New South Wales, Australia

GSK Investigational Site, Carina Heights, Queensland, Australia

GSK Investigational Site, Kippa Ring, Queensland, Australia

GSK Investigational Site, Bedford Park, South Australia, Australia

GSK Investigational Site, Port Lincoln, South Australia, Australia

GSK Investigational Site, Toorak Gardens, South Australia, Australia

GSK Investigational Site, Box Hill, Victoria, Australia

GSK Investigational Site, Carlton, Victoria, Australia

GSK Investigational Site, Fremantle, Western Australia, Australia

GSK Investigational Site, Nedlands, Western Australia, Australia

GSK Investigational Site, Coquitlam, British Columbia, Canada

GSK Investigational Site, Winnipeg, Manitoba, Canada

GSK Investigational Site, Moncton, New Brunswick, Canada

GSK Investigational Site, St. John's, Newfoundland and Labrador, Canada

GSK Investigational Site, Mississauga, Ontario, Canada

GSK Investigational Site, North Bay, Ontario, Canada

GSK Investigational Site, North York, Ontario, Canada

GSK Investigational Site, Sudbury, Ontario, Canada

GSK Investigational Site, Bonaventure, Quebec, Canada

GSK Investigational Site, Saint Romuald, Quebec, Canada

GSK Investigational Site, Trois-Rivieres, Quebec, Canada

GSK Investigational Site, Boulogne, , France

GSK Investigational Site, Grenoble, , France

GSK Investigational Site, Montpellier Cedex 5, , France

GSK Investigational Site, Paris Cedex 4, , France

GSK Investigational Site, Paris, , France

GSK Investigational Site, Paris, , France

GSK Investigational Site, Budapest, , Hungary

GSK Investigational Site, Budapest, , Hungary

GSK Investigational Site, Csongrád, , Hungary

GSK Investigational Site, Heves, , Hungary

GSK Investigational Site, Alkmaar, , Netherlands

GSK Investigational Site, Breda, , Netherlands

GSK Investigational Site, Roosendaal, , Netherlands

GSK Investigational Site, Rotterdam, , Netherlands

GSK Investigational Site, Utrecht, , Netherlands

GSK Investigational Site, Christchurch, , New Zealand

GSK Investigational Site, Hamilton, , New Zealand

GSK Investigational Site, Tauranga, , New Zealand

GSK Investigational Site, Oslo, , Norway

GSK Investigational Site, Oslo, , Norway

GSK Investigational Site, Paradis, , Norway

GSK Investigational Site, Rådahl, , Norway

GSK Investigational Site, Skien, , Norway

GSK Investigational Site, Athlone, Cape Town, , South Africa

GSK Investigational Site, Erasmuskloof, Pretoria, , South Africa

GSK Investigational Site, Fourways, Johannesburg, , South Africa

GSK Investigational Site, Kempton Park, , South Africa

GSK Investigational Site, Kenilworth, Cape Town, , South Africa

GSK Investigational Site, Lynnwood, Pretoria, , South Africa

GSK Investigational Site, Tygervalley, , South Africa

GSK Investigational Site, Westridge, Mitchells Plain, , South Africa

GSK Investigational Site, Alcorcon, , Spain

GSK Investigational Site, Barcelona, , Spain

GSK Investigational Site, El Ferrol, , Spain

GSK Investigational Site, Granada, , Spain

GSK Investigational Site, Madrid, , Spain

GSK Investigational Site, Madrid, , Spain

GSK Investigational Site, Santander, , Spain

GSK Investigational Site, Valencia, , Spain

GSK Investigational Site, Jönköping, , Sweden

GSK Investigational Site, Karlstad, , Sweden

GSK Investigational Site, Linköping, , Sweden

GSK Investigational Site, Stockholm, , Sweden

GSK Investigational Site, Bern, , Switzerland

GSK Investigational Site, Nottwil, , Switzerland

Contact Details

Name: GSK Clinical Trials, MD

Affiliation: GlaxoSmithKline

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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