Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain
NCT ID: NCT00256932
Last Updated: 2015-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
518 participants
INTERVENTIONAL
2005-08-31
2006-05-31
Brief Summary
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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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Placebo
Placebo
Alvimopan 0.5 mg once daily
alvimopan
0.5 mg
alvimopan 0.5 mg twice daily
alvimopan
0.5 mg
Interventions
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alvimopan
0.5 mg
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials, MD
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Calera, Alabama, United States
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Muscle Shoals, Alabama, United States
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Tallassee, Alabama, United States
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Glendale, Arizona, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Sun City, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Hot Springs, Arkansas, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Anaheim, California, United States
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Beuna Park, California, United States
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Burbank, California, United States
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Duarte, California, United States
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Fountain Valley, California, United States
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Huntington Beach, California, United States
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Mission Viejo, California, United States
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Orange, California, United States
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Redlands, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Diego, California, United States
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Vista, California, United States
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Waterbury, Connecticut, United States
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Newark, Delaware, United States
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Brandon, Florida, United States
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Brooksville, Florida, United States
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DeLand, Florida, United States
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Fort Meyers, Florida, United States
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Gainsville, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Jupiter, Florida, United States
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Largo, Florida, United States
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Melbourne, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Niceville, Florida, United States
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North Miami, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Ormond Beach, Florida, United States
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Sarasota, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Winter Park, Florida, United States
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Atlanta, Georgia, United States
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Dawsonville, Georgia, United States
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Decatur, Georgia, United States
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Decatur, Georgia, United States
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Marietta, Georgia, United States
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Bloomington, Illinois, United States
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Rockford, Illinois, United States
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Elkhart, Indiana, United States
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Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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Indianapolis, Indiana, United States
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Newburgh, Indiana, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Elkridge, Maryland, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Portage, Michigan, United States
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Saginaw, Michigan, United States
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Chaska, Minnesota, United States
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Picayune, Mississippi, United States
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Fenton, Missouri, United States
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Manchester, Missouri, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Incline Village, Nevada, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Elizabeth, New Jersey, United States
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Haddon Heights, New Jersey, United States
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Princeton, New Jersey, United States
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East Syracuse, New York, United States
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New York, New York, United States
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New York, New York, United States
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Valley Stream, New York, United States
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Charlotte, North Carolina, United States
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Charlotte, North Carolina, United States
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Concord, North Carolina, United States
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Greensboro, North Carolina, United States
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Salisbury, 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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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Dayton, Ohio, United States
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Maumee, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Eugene, Oregon, United States
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Medford, Oregon, United States
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Oregon City, Oregon, United States
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Portland, Oregon, United States
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Portland, Oregon, United States
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Portland, Oregon, United States
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Bala-Cynwyd, Pennsylvania, United States
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Nazareth, Pennsylvania, United States
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Whitehall, Pennsylvania, United States
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Wyomissing, Pennsylvania, United States
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Warwick, Rhode Island, United States
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Woonsocket, Rhode Island, United States
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Charleston, South Carolina, United States
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Murrells Inlet, South Carolina, United States
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Spartanburg, South Carolina, United States
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Arlington, Texas, United States
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Brownwood, Texas, United States
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Colleyville, Texas, United States
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Galveston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Lake Jackson, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Alexandria, Virginia, United States
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Chesapeake, Virginia, United States
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Christiansburg, Virginia, United States
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Danville, Virginia, United States
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Virginia Beach, Virginia, United States
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Bellingham, Washington, United States
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Edmonds, Washington, United States
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Lacey, Washington, United States
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Spokane, Washington, United States
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Vienna, , Austria
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Vienna, , Austria
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Edmonton, Alberta, Canada
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Kelowna, British Columbia, Canada
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Langley, British Columbia, Canada
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St. John's, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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Brampton, Ontario, Canada
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Kitchener, Ontario, Canada
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Toronto, Ontario, Canada
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Chandler, Quebec, Canada
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Mirabel, Quebec, Canada
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Montreal, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Hvidovre, , Denmark
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Ishøj, , Denmark
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Odense C, , Denmark
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Tallinn, , Estonia
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Helsinki, , Finland
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Fellbach, Baden-Wurttemberg, Germany
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Freiburg im Breisgau, Baden-Wurttemberg, Germany
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Villingen-Schwenningen, Baden-Wurttemberg, Germany
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Weinheim, Baden-Wurttemberg, Germany
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Augsburg, Bavaria, Germany
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Nuremberg, Bavaria, Germany
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Hamburg, City state of Hamburg, Germany
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Hamburg, City state of Hamburg, Germany
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Hamburg, City state of Hamburg, Germany
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Hüttenberg, Hesse, Germany
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Wiesbaden, Hesse, Germany
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Schwerin, Mecklenburg-Vorpommern, Germany
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Cologne, North Rhine-Westphalia, Germany
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Cologne, North Rhine-Westphalia, Germany
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Essen, North Rhine-Westphalia, Germany
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Viersen, North Rhine-Westphalia, Germany
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Witten, North Rhine-Westphalia, Germany
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Chemnitz, Saxony, Germany
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Dresden, Saxony, Germany
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Kiel, Schleswig-Holstein, Germany
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Pinneberg, Schleswig-Holstein, Germany
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Berlin, State of Berlin, Germany
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Berlin, State of Berlin, Germany
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Berlin, State of Berlin, Germany
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Berlin, State of Berlin, Germany
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Berlin, State of Berlin, Germany
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Cork, , Ireland
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Gdansk, , Poland
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Krakow, , Poland
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Wroclaw, , Poland
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Reading, Berkshire, United Kingdom
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Slough, Berkshire, United Kingdom
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Cardiff, Glamorgan, United Kingdom
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Glasgow, Lanarkshire, United Kingdom
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Glasgow, Lanarkshire, United Kingdom
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Blackpool, Lancashire, United Kingdom
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Ashford, Middlesex, United Kingdom
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Sunbury-on-Thames, Middlesex, United Kingdom
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Coventry, Warwickshire, United Kingdom
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Bexhill-on-Sea, East Sussex, , United Kingdom
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Leeds, , United Kingdom
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London, , United Kingdom
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Yaxley, Peterborough, , United Kingdom
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York, , United Kingdom
Countries
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References
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Jansen JP, Lorch D, Langan J, Lasko B, Hermanns K, Kleoudis CS, Snidow JW, Pierce A, Wurzelmann J, Mortensen ER. A randomized, placebo-controlled phase 3 trial (Study SB-767905/012) of alvimopan for opioid-induced bowel dysfunction in patients with non-cancer pain. J Pain. 2011 Feb;12(2):185-93. doi: 10.1016/j.jpain.2010.06.012.
Other Identifiers
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SB-767905/012
Identifier Type: -
Identifier Source: org_study_id
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