Spots Global Cancer Trial Database for Long-Term Safety Evaluation Of Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain
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Trial Identification
Brief Title: Long-Term Safety Evaluation Of 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 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
Study ID: NCT00241722
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) 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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GSK Investigational Site, Dayton, Ohio, United States
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GSK Investigational Site, Clinton, Oklahoma, United States
GSK Investigational Site, Oklahoma City, Oklahoma, United States
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GSK Investigational Site, Carnegie, Pennsylvania, United States
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GSK Investigational Site, Chattanooga, Tennessee, United States
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GSK Investigational Site, Broadmeadow, New South Wales, Australia
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GSK Investigational Site, Bedford Park, South Australia, Australia
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GSK Investigational Site, Toorak Gardens, South Australia, Australia
GSK Investigational Site, Box Hill, Victoria, Australia
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GSK Investigational Site, Vienna, , Austria
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GSK Investigational Site, Langley, British Columbia, Canada
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GSK Investigational Site, Brampton, Ontario, Canada
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GSK Investigational Site, Kitchener, Ontario, Canada
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GSK Investigational Site, North York, Ontario, Canada
GSK Investigational Site, Sudbury, Ontario, Canada
GSK Investigational Site, Toronto, Ontario, Canada
GSK Investigational Site, Toronto, Ontario, Canada
GSK Investigational Site, Toronto, Ontario, Canada
GSK Investigational Site, Toronto, Ontario, Canada
GSK Investigational Site, Charlottetown, Prince Edward Island, Canada
GSK Investigational Site, Bonaventure, Quebec, Canada
GSK Investigational Site, Chandler, Quebec, Canada
GSK Investigational Site, Drummondville, Quebec, Canada
GSK Investigational Site, Mirabel, Quebec, Canada
GSK Investigational Site, Montreal, Quebec, Canada
GSK Investigational Site, Saint Romuald, Quebec, Canada
GSK Investigational Site, Sherbrooke, Quebec, Canada
GSK Investigational Site, Trois-Rivieres, Quebec, Canada
GSK Investigational Site, Ishoj, , Denmark
GSK Investigational Site, Helsinki, , Finland
GSK Investigational Site, Kowloon, , Hong Kong
GSK Investigational Site, Kwun Tong, , Hong Kong
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GSK Investigational Site, Shatin, , Hong Kong
GSK Investigational Site, Budapest, , Hungary
GSK Investigational Site, Cork, , Ireland
GSK Investigational Site, Roosendaal, , 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, Gdansk, , Poland
GSK Investigational Site, Krakow, , Poland
GSK Investigational Site, Wroclaw, , Poland
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
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GSK Investigational Site, Valencia, , Spain
GSK Investigational Site, Jönköping, , Sweden
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GSK Investigational Site, Linköping, , Sweden
GSK Investigational Site, Stockholm, , Sweden
GSK Investigational Site, Bern, , Switzerland
GSK Investigational Site, Tainan, , Taiwan
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GSK Investigational Site, Reading, Berkshire, United Kingdom
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GSK Investigational Site, Cardiff, Glamorgan, United Kingdom
GSK Investigational Site, Glasgow, Lanarkshire, United Kingdom
GSK Investigational Site, Glasgow, Lanarkshire, United Kingdom
GSK Investigational Site, Sunbury-on-Thames, Middlesex, United Kingdom
GSK Investigational Site, Coventry, Warwickshire, United Kingdom
GSK Investigational Site, Bexhill-on-Sea, East Sussex, , United Kingdom
GSK Investigational Site, Leeds, , United Kingdom
GSK Investigational Site, London, , United Kingdom
GSK Investigational Site, Yaxley, Peterborough, , United Kingdom
Contact Details
Name: GSK Clinical Trials, MD
Affiliation: GlaxoSmithKline
Role: STUDY_DIRECTOR
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