Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1246 participants
INTERVENTIONAL
2013-09-24
2016-01-12
Brief Summary
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Efficacy and Safety of Naldemedine in the Treatment of Opioid-induced Constipation
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Naldemedine
Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
Naldemedine
Naldemedine 0.2 mg tablet taken orally once a day
Placebo
Participants received matching placebo tablets orally once daily for 52 weeks.
Placebo
Placebo tablet taken orally once a day
Interventions
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Naldemedine
Naldemedine 0.2 mg tablet taken orally once a day
Placebo
Placebo tablet taken orally once a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects must have non-malignant chronic pain treated and must have opioid induced constipation (OIC)
3. Subjects must be treated with a stable opioid regimen at a total daily dose on average of ≥ 30 mg equivalents of oral morphine sulfate
4. Subjects may or may not be on a routine laxative regimen at the time of Screening
Exclusion Criteria
2. Evidence of active medical diseases affecting bowel transit
3. History of pelvic disorders that may be a cause of constipation
4. Surgery (except for minor procedures) within 60 days of Screening
5. History of chronic constipation prior to starting analgesic medication or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation (e.g. mechanical GI obstruction)
6. Subjects who have never taken laxatives for the treatment of OIC
7. Current use of any prohibited medication including opioid antagonists, partial or mixed agonists/antagonists
18 Years
80 Years
ALL
No
Sponsors
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Shionogi
INDUSTRY
Responsible Party
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Principal Investigators
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Shionogi Clinical Trials Administrator Clinical Support Help Line
Role: STUDY_DIRECTOR
Shionogi
Locations
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Shionogi Research Site
Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Chandler, Arizona, United States
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Glendale, Arizona, United States
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Goodyear, Arizona, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Fountain Valley, California, United States
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Garden Grove, California, United States
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Glendale, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Oceanside, California, United States
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Sacramento, California, United States
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Santa Ana, California, United States
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Upland, California, United States
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Colorado Springs, Colorado, United States
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Boynton Beach, Florida, United States
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Brandon, Florida, United States
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Brooksville, Florida, United States
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Clearwater, Florida, United States
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Fort Myers, Florida, United States
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Jacksonville, Florida, United States
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Lake City, Florida, United States
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Lakeland, Florida, United States
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Orlando, Florida, United States
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South Miami, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Blue Ridge, Georgia, United States
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Decatur, Georgia, United States
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Savannah, Georgia, United States
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Boise, Idaho, United States
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Aurora, Illinois, United States
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Bloomington, Illinois, United States
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Decatur, Illinois, United States
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Rockford, Illinois, United States
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Schaumburg, Illinois, United States
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Evansville, Indiana, United States
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Lafayette, Indiana, United States
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Valparaiso, Indiana, United States
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Augusta, Kansas, United States
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Newton, Kansas, United States
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Wichita, Kansas, United States
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Hartford, Kentucky, United States
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Eunice, Louisiana, United States
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Lake Charles, Louisiana, United States
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Mandeville, Louisiana, United States
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Brockton, Massachusetts, United States
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Fall River, Massachusetts, United States
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New Bedford, Massachusetts, United States
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Rochester, Michigan, United States
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Saginaw, Michigan, United States
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Traverse City, Michigan, United States
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Biloxi, Mississippi, United States
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Fremont, Nebraska, United States
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Omaha, Nebraska, United States
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Henderson, Nevada, United States
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Las Vegas, Nevada, United States
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Trenton, New Jersey, United States
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Albuquerque, New Mexico, United States
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New York, New York, United States
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Greensboro, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Akron, Ohio, United States
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Canton, Ohio, United States
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Columbus, Ohio, United States
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Groveport, Ohio, United States
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Kettering, Ohio, United States
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Lebanon, Ohio, United States
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Marion, Ohio, United States
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Munroe Falls, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Portland, Oregon, United States
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Huntingdon Valley, Pennsylvania, United States
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Jenkintown, Pennsylvania, United States
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Lansdale, Pennsylvania, United States
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Charleston, South Carolina, United States
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Greer, South Carolina, United States
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Myrtle Beach, South Carolina, United States
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Summerville, South Carolina, United States
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Bristol, Tennessee, United States
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Milan, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Hurst, Texas, United States
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Sugar Land, Texas, United States
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Bountiful, Utah, United States
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Salt Lake City, Utah, United States
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South Ogden, Utah, United States
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Richmond, Virginia, United States
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Bellevue, Washington, United States
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Edmonds, Washington, United States
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Adelaide, , Australia
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Bedford Park, , Australia
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Camperdown, , Australia
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Carina Heights, , Australia
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Caulfield South, , Australia
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Malvern East, , Australia
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Nambour, , Australia
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Sherwood, , Australia
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St Leonards, , Australia
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Linz, , Austria
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Vienna, , Austria
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Zams, , Austria
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London, , Canada
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Mirabel, , Canada
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Sarnia, , Canada
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Sherbrooke, , Canada
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Toronto, , Canada
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Vancouver, , Canada
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Benešov, , Czechia
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Olomouc, , Czechia
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Ostrava, , Czechia
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Pardubice, , Czechia
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Pribram V- Zdabor, , Czechia
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Glostrup Municipality, , Denmark
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Hellerup, , Denmark
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Odense, , Denmark
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Soulaine Sur Aubance, , France
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Berlin, , Germany
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Dresden, , Germany
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Halle, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Kassel, , Germany
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Leipzig, , Germany
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Lünen, , Germany
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Mainz, , Germany
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Münster, , Germany
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Stadtroda, , Germany
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Balatonfüred, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Hatvan, , Hungary
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Szikszó, , Hungary
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Beersheba, , Israel
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Haifa, , Israel
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Tel Aviv, , Israel
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Tel Litwinsky, , Israel
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Asti, , Italy
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Catania, , Italy
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Chieti, , Italy
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Florence, , Italy
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Napoli, , Italy
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Rionero in Vulture, , Italy
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Roma, , Italy
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Rome, , Italy
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Chorzów, , Poland
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Gdansk, , Poland
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Katowice, , Poland
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Lublin, , Poland
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Alberton, , South Africa
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Lyttelton Centurion, , South Africa
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Muckleneuk Pretoria, , South Africa
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Pretoria West Pretoria, , South Africa
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Worcester, , South Africa
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Barcelona, , Spain
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Girona, , Spain
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Seville, , Spain
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Skene, , Sweden
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Stockholm, , Sweden
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Bath, , United Kingdom
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Belfast, , United Kingdom
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Bexhill on Sea East Sussex, , United Kingdom
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Chesterfield, , United Kingdom
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Chestfield Kent, , United Kingdom
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Daventry Northants, , United Kingdom
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Devon, , United Kingdom
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Epworth Doncaster, , United Kingdom
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Harrogate, , United Kingdom
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Hinckley, , United Kingdom
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Liverpool, , United Kingdom
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Norwich, , United Kingdom
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Oldham, , United Kingdom
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Peterborough, , United Kingdom
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Randalstown, County Antrim, , United Kingdom
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Spiro Close, Pulborough West Sussex, , United Kingdom
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Wellingborough Northamptonshire, , United Kingdom
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York, , United Kingdom
Countries
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References
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Camilleri M, Hale M, Morlion B, Tack J, Webster L, Wild J. Naldemedine Improves Patient-Reported Outcomes of Opioid-Induced Constipation in Patients with Chronic Non-Cancer Pain in the COMPOSE Phase 3 Studies. J Pain Res. 2021 Jul 16;14:2179-2189. doi: 10.2147/JPR.S282738. eCollection 2021.
Webster LR, Hale ME, Yamada T, Wild JE. A Renal Impairment Subgroup Analysis of the Safety and Efficacy of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Chronic Non-Cancer Pain Receiving Opioid Therapy. J Pain Res. 2020 Mar 24;13:605-612. doi: 10.2147/JPR.S237833. eCollection 2020.
Wild J, Webster L, Yamada T, Hale M. Safety and Efficacy of Naldemedine for the Treatment of Opioid-Induced Constipation in Patients with Chronic Non-Cancer Pain Receiving Opioid Therapy: A Subgroup Analysis of Patients >/= 65 Years of Age. Drugs Aging. 2020 Apr;37(4):271-279. doi: 10.1007/s40266-020-00753-2.
Other Identifiers
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1326V9235
Identifier Type: -
Identifier Source: org_study_id
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