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

NCT00241722 | Completed Phase 3

• 2 other identifiers: 3753-013SB-767905/014
• Study Type: interventional
• Target: 805
• Locations: 16 countries
• Sites: 217

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.

Conditions

Bowel Dysfunction; Constipation

Keywords

bowel dysfunction; constipation; gastrointestinal; opioids; pain; non-cancer pain; opioid-induced

Outcome Measures

Primary Outcomes (1)

• To compare alvimopan with placebo for long-term safety and tolerability

  12 months

Secondary Outcomes (1)

• Quality of life, pharmacokinetics, pharmacogenetics (dependent on results from other data)

  12 months

Study Arms (2)

Alvimopan 0.5 mg Twice Daily (BID)

EXPERIMENTAL

0.5 milligrams (mg) of alvimopan was administered orally twice daily (BID) for 12 months.

Drug: Alvimopan

Placebo

PLACEBO COMPARATOR

Placebo was administered orally BID for 12 months.

Drug: Placebo

Interventions

Alvimopan DRUG

Alvimopan 0.5 mg Twice Daily (BID)

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): lead
• GlaxoSmithKline: collaborator

Study Sites (227)

GSK Investigational Site

Birmingham, Alabama, 35215, United States

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GSK Investigational Site

Birmingham, Alabama, 35242, United States

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GSK Investigational Site

Birmingham, Alabama, 35244, United States

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Huntsville, Alabama, 35801, United States

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GSK Investigational Site

Mobile, Alabama, 36606, United States

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Muscle Shoals, Alabama, 35662, United States

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GSK Investigational Site

Northport, Alabama, 35476, United States

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Glendale, Arizona, 85306, United States

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Phoenix, Arizona, 85023, United States

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Phoenix, Arizona, 85029, United States

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GSK Investigational Site

Phoenix, Arizona, 85032, United States

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Scottsdale, Arizona, 85251, United States

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GSK Investigational Site

Scottsdale, Arizona, 85258, United States

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GSK Investigational Site

Sun City, Arizona, 85351, United States

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Tempe, Arizona, 85282, United States

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Tucson, Arizona, 85712, United States

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Tucson, Arizona, 85741, United States

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Hot Springs, Arkansas, 71913, United States

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Little Rock, Arkansas, 72223, United States

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Anaheim, California, 92801, United States

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Anaheim, California, 92805, United States

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Bakersfield, California, 93311, United States

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Beverly Hills, California, 90211, United States

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Buena Park, California, 90620, United States

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Burbank, California, 91505, United States

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Los Gatos, California, 95032, United States

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Orange, California, 92868, United States

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Palm Springs, California, 92262, United States

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Pismo Beach, California, 93449, United States

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San Diego, California, 92108, United States

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San Diego, California, 92120, United States

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San Diego, California, 92121, United States

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Torrance, California, 90503, United States

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Vista, California, 92083, United States

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Stratford, Connecticut, 6497, United States

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Trumbull, Connecticut, 06611, United States

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Brandon, Florida, 33511, United States

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Chiefland, Florida, 32626, United States

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Clearwater, Florida, 33756, United States

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Clearwater, Florida, 33765, United States

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Deerfield Beach, Florida, 33441, United States

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DeLand, Florida, 32720, United States

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Fort Myers, Florida, 33907, United States

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Gainesville, Florida, 32607, United States

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Holly Hill, Florida, 32117, United States

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Hollywood, Florida, 33021, United States

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Jupiter, Florida, 33458, United States

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Miami, Florida, 33169, United States

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Ocala, Florida, 32607, United States

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Ocala, Florida, 34471, United States

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Orlando, Florida, 32804, United States

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Ormond Beach, Florida, 32174, United States

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Saint Cloud, Florida, 34769, United States

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West Palm Beach, Florida, 33409, United States

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Dawsonville, Georgia, 30534, United States

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Marietta, Georgia, 30066, United States

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Stockbridge, Georgia, 30281, United States

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Suwanee, Georgia, 30024, United States

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Boise, Idaho, 83702, United States

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Meridian, Idaho, 83642, United States

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Arlington Heights, Illinois, 60005, United States

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Bloomington, Illinois, 61701, United States

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Chicago, Illinois, 60610, United States

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Rockford, Illinois, 61107, United States

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Elkhart, Indiana, 46515, United States

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Indianapolis, Indiana, 46250, United States

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Louisville, Kentucky, 40205, United States

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Louisville, Kentucky, 40213, United States

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Madisonville, Kentucky, 42431, United States

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Baton Rouge, Louisiana, 70808, United States

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Shreveport, Louisiana, 71103, United States

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Pasadena, Maryland, 21122, United States

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Rockville, Maryland, 20852, United States

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Boston, Massachusetts, 02115, United States

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Brockton, Massachusetts, 02301, United States

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Wellesley Hills, Massachusetts, 02481, United States

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Detroit, Michigan, 48202, United States

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Grand Blanc, Michigan, 48439, United States

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Portage, Michigan, 49024, United States

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Traverse City, Michigan, 49684, United States

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Chaska, Minnesota, 55318, United States

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Olive Branch, Mississippi, 38654, United States

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Manchester, Missouri, 63021, United States

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Nixa, Missouri, 65714, United States

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St Louis, Missouri, 63108, United States

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Missoula, Montana, 59804, United States

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Omaha, Nebraska, 68114, United States

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Henderson, Nevada, 89015, United States

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Las Vegas, Nevada, 89102, United States

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GSK Investigational Site

Las Vegas, Nevada, 89103, United States

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GSK Investigational Site

Las Vegas, Nevada, 89119, United States

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Dover, New Hampshire, 03820, United States

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Blackwood, New Jersey, 08012, United States

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Elizabeth, New Jersey, 07202, United States

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Albuquerque, New Mexico, 87102, United States

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Lake Success, New York, 11042, United States

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Asheville, North Carolina, 28801, United States

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Charlotte, North Carolina, 28204, United States

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Concord, North Carolina, 28025, United States

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Greensboro, North Carolina, 27401, United States

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Greensboro, North Carolina, 27403, United States

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Hickory, North Carolina, 28601, United States

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Raleigh, North Carolina, 27607, United States

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Winston-Salem, North Carolina, 27103, United States

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Centerville, Ohio, 45450, United States

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Cincinnati, Ohio, 45219, United States

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Cincinnati, Ohio, 45224, United States

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Columbus, Ohio, 43215, United States

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Dayton, Ohio, 45408, United States

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Dayton, Ohio, 45439, United States

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GSK Investigational Site

Dayton, Ohio, 46432, United States

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Clinton, Oklahoma, 73601, United States

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GSK Investigational Site

Oklahoma City, Oklahoma, 73112, United States

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Medford, Oregon, 97504, United States

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Oregon City, Oregon, 97045, United States

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Portland, Oregon, 97210, United States

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Carnegie, Pennsylvania, 15106, United States

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Pittsburgh, Pennsylvania, 15243, United States

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Reading, Pennsylvania, 19611, United States

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Woonsocket, Rhode Island, 02895, United States

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Chattanooga, Tennessee, 37403, United States

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Clarksville, Tennessee, 37043, United States

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Kingsport, Tennessee, 37660, United States

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Arlington, Texas, 76017, United States

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Brownwood, Texas, 76801, United States

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Dallas, Texas, 75218, United States

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Grand Prairie, Texas, 75052, United States

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Houston, Texas, 77074, United States

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Houston, Texas, 77090, United States

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Lake Jackson, Texas, 77566, United States

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Lancaster, Texas, 75146, United States

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Richardson, Texas, 75080, United States

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San Antonio, Texas, 78238, United States

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Salt Lake City, Utah, 84106, United States

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Salt Lake City, Utah, 84120, United States

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Norfolk, Virginia, 23502, United States

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Richmond, Virginia, 23294, United States

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Virginia Beach, Virginia, 23452, United States

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Bellingham, Washington, 98226, United States

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Edmonds, Washington, 98026, United States

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Spokane, Washington, 99204, United States

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Tacoma, Washington, 98405, United States

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Charleston, West Virginia, 25304, United States

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Broadmeadow, New South Wales, 2292, Australia

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St Leonards, New South Wales, 2065, Australia

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Carina Heights, Queensland, 4152, Australia

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Kippa-Ring, Queensland, 4021, Australia

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Bedford Park, South Australia, 5042, Australia

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Port Lincoln, South Australia, 5606, Australia

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Toorak Gardens, South Australia, 5065, Australia

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Box Hill, Victoria, 3128, Australia

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Carlton, Victoria, 3053, Australia

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Fremantle, Western Australia, 6160, Australia

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Vienna, A-1100, Austria

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Vienna, A-1130, Austria

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Calgary, Alberta, T3C 3P1, Canada

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Edmonton, Alberta, T5A 4L8, Canada

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Coquitlam, British Columbia, V3K 3P4, Canada

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Kelowna, British Columbia, V1Y 2H4, Canada

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Langley, British Columbia, V3A 4H9, Canada

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Winnipeg, Manitoba, R3A 1R9, Canada

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Moncton, New Brunswick, E1G 1A7, Canada

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St. John's, Newfoundland and Labrador, A1E 2C2, Canada

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Halifax, Nova Scotia, B3K 5R3, Canada

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Brampton, Ontario, L6T 3J1, Canada

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Greater Sudbury, Ontario, P3E 1H5, Canada

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Hamilton, Ontario, L8L 5G8, Canada

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Kitchener, Ontario, N2M 5N6, Canada

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Mississauga, Ontario, L4T 4J2, Canada

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North Bay, Ontario, P1B 2H3, Canada

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North York, Ontario, M2M 4E7, Canada

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Toronto, Ontario, M3H 5S4, Canada

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Toronto, Ontario, M3J 1N2, Canada

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Toronto, Ontario, M3N 2V7, Canada

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Toronto, Ontario, M9W 4L6, Canada

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Charlottetown, Prince Edward Island, C1A 8T5, Canada

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Bonaventure, Quebec, G0C 1E0, Canada

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Chandler, Quebec, G0C 1K0, Canada

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Drummondville, Quebec, J2B 1H8, Canada

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Mirabel, Quebec, J7J 2K8, Canada

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Montreal, Quebec, H3M 3A9, Canada

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Saint Romuald, Quebec, G6W 5M6, Canada

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Sherbrooke, Quebec, J1H 1Z1, Canada

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Trois-Rivières, Quebec, G8Z 1Y2, Canada

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Ishøj, 2635, Denmark

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Helsinki, 00029, Finland

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Kowloon, Hong Kong

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GSK Investigational Site

Kwun Tong, Hong Kong

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Pokfulam, Hong Kong

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Shatin, Hong Kong

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Budapest, 1083, Hungary

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Cork, Ireland

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Roosendaal, 4708 AE, Netherlands

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Utrecht, 3584 CX, Netherlands

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Christchurch, New Zealand

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Hamilton, 2001, New Zealand

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Tauranga, 3001, New Zealand

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Gdansk, 80-952, Poland

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Krakow, 31-531, Poland

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Wroclaw, 50-368, Poland

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Alcorcón, 28922, Spain

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Barcelona, 08003, Spain

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Ferrol, Spain

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Granada, 18012, Spain

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Madrid, 28006, Spain

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GSK Investigational Site

Madrid, 28034, Spain

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Santander, 39008, Spain

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Valencia, 46014, Spain

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Jönköping, SE-551 85, Sweden

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Karlstad, SE-651 85, Sweden

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Linköping, SE-581 85, Sweden

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Stockholm, SE-141 86, Sweden

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Bern, 3011, Switzerland

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Tainan, 704, Taiwan

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Taipei, 100, Taiwan

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GSK Investigational Site

Taipei, 114, Taiwan

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Reading, Berkshire, RG7 3SQ, United Kingdom

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Slough, Berkshire, SL2 1HD, United Kingdom

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Cardiff, Glamorgan, CF14 9BB, United Kingdom

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GSK Investigational Site

Glasgow, Lanarkshire, G3 8YJ, United Kingdom

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GSK Investigational Site

Glasgow, Lanarkshire, G69 7AD, United Kingdom

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GSK Investigational Site

Sunbury-on-Thames, Middlesex, TW16 6RH, United Kingdom

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Coventry, Warwickshire, CV6 4DD, United Kingdom

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Bexhill-on-Sea, East Sussex, TN39 4SP, United Kingdom

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GSK Investigational Site

Leeds, LS14 6UH, United Kingdom

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London, EC1A 7BE, United Kingdom

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Yaxley, Peterborough, PE7 3JL, United Kingdom

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MeSH Terms

Conditions

Intestinal Diseases; Constipation; Pain

Interventions

alvimopan

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Study Officials

• GSK Clinical Trials, MD

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2005
• First Posted: October 19, 2005
• Study Start: August 1, 2005
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: August 30, 2017

Record last verified: 2017-08

Locations

DK (1); CH (1); HU (1); PL (3); TW (3); GB (11); NZ (3); US (143); FI (1); IE (1); NL (2); ES (8); SE (4); CA (29); AU (2); HK (4)