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

NCT00259922 | Completed Phase 3

• 1 other identifier: SB-767905/013
• Study Type: interventional
• Target: 485
• Locations: 12 countries
• Sites: 187

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.

Conditions

Bowel Dysfunction; Constipation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• To compare alvimopan with placebo for efficacy in the treatment of OBD

Secondary Outcomes (1)

• Safety and tolerability, quality of life, pharmacogenetics (dependent on results from other data)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Alvimopan 0.5 mg once daily

EXPERIMENTAL

0.5 mg once daily (QD)

Drug: Alvimopan

Alvimopan 0.5 mg twice daily

EXPERIMENTAL

0.5 mg twice daily (BID)

Drug: Alviompan

Interventions

Placebo DRUG

Placebo

Placebo

Alvimopan DRUG

0.5 mg QD

Also known as: Entereg

Alvimopan 0.5 mg once daily

Alviompan DRUG

0.5 mg BID

Also known as: Entereg

Alvimopan 0.5 mg twice daily

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).
• Willing to report daily bowel symptoms.

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.
• 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 (187)

GSK Investigational Site

Birmingham, Alabama, 35215, United States

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GSK Investigational Site

Birmingham, Alabama, 35216, United States

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GSK Investigational Site

Huntsville, Alabama, 35801, United States

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GSK Investigational Site

Mobile, Alabama, 36606, United States

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GSK Investigational Site

Northport, Alabama, 35476, United States

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GSK Investigational Site

Mesa, Arizona, 85205, United States

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GSK Investigational Site

Phoenix, Arizona, 85029, United States

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GSK Investigational Site

Scottsdale, Arizona, 85251, United States

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GSK Investigational Site

Scottsdale, Arizona, 85258, United States

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Tempe, Arizona, 85282, United States

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Tucson, Arizona, 85712, United States

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GSK Investigational Site

Tucson, Arizona, 85724, 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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Long Beach, California, 90813, United States

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Los Angeles, California, 90048, United States

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Los Gatos, California, 95032, United States

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Northridge, California, 91325, 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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Pasadena, California, 91105, United States

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Sacramento, California, 95816, United States

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San Diego, California, 92108, United States

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San Rafael, California, 94901, United States

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Santa Ana, California, 92704, United States

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Stamford, Connecticut, 06905, United States

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Waterbury, Connecticut, 06708, United States

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Washington D.C., District of Columbia, 20003, United States

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Chiefland, Florida, 32626, United States

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Clearwater, Florida, 33761, United States

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Deerfield Beach, Florida, 33441, United States

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Destin, Florida, 32541, United States

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Fort Myers, Florida, 33916, United States

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Hollywood, Florida, 33021, United States

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Hollywood, Florida, 33023, United States

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Largo, Florida, 33770, United States

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Margate, Florida, 33063, United States

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Miami, Florida, 33138, United States

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Miami, Florida, 33155, United States

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Miami, Florida, 33169, United States

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Ocala, Florida, 34471, 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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Tampa, Florida, 33614, United States

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West Palm Beach, Florida, 33401, United States

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Winterhaven, Florida, 33880, United States

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Atlanta, Georgia, 30338, United States

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Atlanta, Georgia, 30342, United States

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Cumming, Georgia, 30040, United States

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Marietta, Georgia, 30066, United States

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Stockbridge, Georgia, 30281, United States

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Meridian, Idaho, 83642, United States

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Chicago, Illinois, 60610, United States

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Libertyville, Illinois, 60048, United States

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Oak Forest, Illinois, 60452, United States

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Oakbrook Terrace, Illinois, 60181, United States

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Evansville, Indiana, 47714, United States

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Indianapolis, Indiana, 46250, United States

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Lexington, Kentucky, 40536, United States

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Louisville, Kentucky, 40205, United States

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Sunset, Louisiana, 70584, 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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Portage, Michigan, 49024, United States

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Waterford, Michigan, 48327, United States

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Olive Branch, Mississippi, 38654, United States

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Independence, Missouri, 64055, United States

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St Louis, Missouri, 63108, United States

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St Louis, Missouri, 63141, United States

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Missoula, Montana, 59804, 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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Las Vegas, Nevada, 89146, 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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Egg Harbor, New Jersey, 08234, United States

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Albuquerque, New Mexico, 87102, United States

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Mineola, New York, 11501, United States

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GSK Investigational Site

New York, New York, 10022, United States

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Rochester, New York, 14627, United States

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Asheville, North Carolina, 28801, 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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GSK Investigational Site

Centerville, Ohio, 45450, United States

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Cincinnati, Ohio, 45236, United States

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Dayton, Ohio, 46432, United States

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Perrysburg, Ohio, 43551, United States

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Eugene, Oregon, 97401, United States

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Medford, Oregon, 97504, United States

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Portland, Oregon, 97210, United States

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Salem, Oregon, 97301, United States

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Levittown, Pennsylvania, 19056, United States

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Pittsburgh, Pennsylvania, 15243, United States

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Reading, Pennsylvania, 19611, United States

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Cranston, Rhode Island, 02920, United States

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Greer, South Carolina, 29651, United States

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Kingsport, Tennessee, 37660, United States

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New Tazewell, Tennessee, 37824-1409, United States

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Austin, Texas, 78756, United States

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Corpus Christi, Texas, 78404, United States

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Galveston, Texas, 77555-0188, United States

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Houston, Texas, 77070, United States

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Richardson, Texas, 75080, United States

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San Antonio, Texas, 78217, United States

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San Antonio, Texas, 78229, United States

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Salt Lake City, Utah, 84107, United States

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Norfolk, Virginia, 23502, United States

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Richmond, Virginia, 23294, United States

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Spokane, Washington, 99207, United States

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Tacoma, Washington, 98405, United States

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Yakima, Washington, 98902, United States

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Charleston, West Virginia, 25304, United States

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La Crosse, Wisconsin, 54601, United States

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Broadmeadow, New South Wales, 2292, Australia

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Newcastle, New South Wales, 2300, 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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Nedlands, Western Australia, 6009, Australia

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Coquitlam, British Columbia, V3K 3V9, 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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Greater Sudbury, Ontario, P3A 1Y8, 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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Bonaventure, Quebec, G0C 1E0, Canada

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Saint Romuald, Quebec, G6W 5M6, Canada

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Trois-Rivières, Quebec, G8Z 1Y2, Canada

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Boulogne, 92100, France

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Grenoble, 38000, France

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Montpellier, 34295, France

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Paris, 75010, France

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Paris, 75012, France

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Paris, 75181, France

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Budapest, 1083, Hungary

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Budapest, 1183, Hungary

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Csongrád, 6640, Hungary

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Heves, 3360, Hungary

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Alkmaar, 1815 JD, Netherlands

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Breda, 4819 EV, Netherlands

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Roosendaal, 4708 AE, Netherlands

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Rotterdam, 3083 AN, 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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Oslo, N-0027, Norway

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Oslo, N-0260, Norway

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Paradis, 5231, Norway

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Rådahl, 5235, Norway

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Skien, N-3710, Norway

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Athlone, Cape Town, 7760, South Africa

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Erasmuskloof, Pretoria, 0048, South Africa

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Fourways, Johannesburg, South Africa

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Kempton Park, 1620, South Africa

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Kenilworth, Cape Town, 7708, South Africa

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Lynnwood, Pretoria, 0040, South Africa

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Tygervalley, 7536, South Africa

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Westridge, Mitchells Plain, 7798, South Africa

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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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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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Nottwil, 6207, Switzerland

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Related Publications (1)

• Irving G, Penzes J, Ramjattan B, Cousins M, Rauck R, Spierings EL, Kleoudis CS, Snidow JW, Pierce A, Wurzelmann J, Mortensen ER. A randomized, placebo-controlled phase 3 trial (Study SB-767905/013) of alvimopan for opioid-induced bowel dysfunction in patients with non-cancer pain. J Pain. 2011 Feb;12(2):175-84. doi: 10.1016/j.jpain.2010.06.013.

  PMID: 21292168 RESULT

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: November 29, 2005
• First Posted: December 1, 2005
• Study Start: August 1, 2005
• Primary Completion: June 1, 2006
• Last Updated: September 2, 2015

Record last verified: 2009-09

Locations

HU (4); SE (4); CA (11); NO (5); ZA (8); CH (2); NL (5); FR (6); US (119); NZ (3); AU (12); ES (8)