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

NCT00256932 | Completed Phase 3

• 1 other identifier: SB-767905/012
• Study Type: interventional
• Target: 518
• Locations: 10 countries
• Sites: 200

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 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

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

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, pharmacokinetics, pharmacogenetics (dependent on results from other data)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Alvimopan 0.5 mg once daily

EXPERIMENTAL

Drug: alvimopan

alvimopan 0.5 mg twice daily

EXPERIMENTAL

Drug: alvimopan

Interventions

alvimopan DRUG

0.5 mg

Also known as: Entereg

Alvimopan 0.5 mg once daily; alvimopan 0.5 mg twice daily

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:

• Has 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 (200)

GSK Investigational Site

Birmingham, Alabama, 35243, United States

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GSK Investigational Site

Birmingham, Alabama, 35244, United States

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Calera, Alabama, 35040, United States

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Muscle Shoals, Alabama, 35662, United States

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Tallassee, Alabama, 36078, 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, 85032, United States

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GSK Investigational Site

Sun City, Arizona, 85351, United States

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Tucson, Arizona, 85711, 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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Beuna Park, California, 90620, United States

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Burbank, California, 91505, United States

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Duarte, California, 91010, United States

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Fountain Valley, California, 92708, United States

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Huntington Beach, California, 92648, United States

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Mission Viejo, California, 92691, United States

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Orange, California, 92869, United States

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Redlands, California, 92374, United States

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San Diego, California, 92103-6204, United States

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GSK Investigational Site

San Diego, California, 92120, United States

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GSK Investigational Site

San Diego, California, 92121, United States

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Vista, California, 92083, United States

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Waterbury, Connecticut, 067708, United States

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Newark, Delaware, 19713, United States

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Brandon, Florida, 33511, United States

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Brooksville, Florida, 34613, United States

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DeLand, Florida, 32720, United States

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Fort Meyers, Florida, 33907, United States

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Gainsville, Florida, 32607, United States

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Hollywood, Florida, 33021, United States

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Jacksonville, Florida, 32256, United States

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Jacksonville, Florida, 32257, United States

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Jupiter, Florida, 33458, United States

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Largo, Florida, 33773, United States

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Melbourne, Florida, 32901, United States

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Miami, Florida, 33145, United States

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Miami, Florida, 33186, United States

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Niceville, Florida, 32578, United States

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North Miami, Florida, 33161, United States

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Ocala, Florida, 32607, 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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Sarasota, Florida, 34239, United States

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St. Petersburg, Florida, 33703, United States

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Tampa, Florida, 33603, United States

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West Palm Beach, Florida, 33409, United States

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Winter Park, Florida, 32789, United States

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Atlanta, Georgia, 30308, United States

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Dawsonville, Georgia, 30534, United States

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Decatur, Georgia, 30033, United States

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Decatur, Georgia, 30034, United States

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Marietta, Georgia, 30066, United States

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Bloomington, Illinois, 61701, United States

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Rockford, Illinois, 61107, United States

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Elkhart, Indiana, 46515, United States

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Evansville, Indiana, 47714, United States

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Indianapolis, Indiana, 46202, United States

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Indianapolis, Indiana, 46250, United States

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Newburgh, Indiana, 47630, United States

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Lexington, Kentucky, 40504, United States

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Louisville, Kentucky, 40213, United States

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Shreveport, Louisiana, 71103, United States

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Baltimore, Maryland, 21229-5299, United States

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Elkridge, Maryland, 21075, United States

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Boston, Massachusetts, 02215, United States

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Detroit, Michigan, 48202, United States

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Portage, Michigan, 49024, United States

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Saginaw, Michigan, 48602, United States

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Chaska, Minnesota, 55318, United States

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Picayune, Mississippi, 39466, United States

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Fenton, Missouri, 63026, United States

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Manchester, Missouri, 63021, United States

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St Louis, Missouri, 63128, United States

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St Louis, Missouri, 63141, United States

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Omaha, Nebraska, 68114, United States

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Incline Village, Nevada, 89452, United States

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Las Vegas, Nevada, 89119, United States

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Las Vegas, Nevada, 89146, United States

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Elizabeth, New Jersey, 07202, United States

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Haddon Heights, New Jersey, 08035, United States

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Princeton, New Jersey, 08540, United States

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East Syracuse, New York, 13057, United States

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GSK Investigational Site

New York, New York, 10010, United States

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New York, New York, 10016, United States

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Valley Stream, New York, 11580, United States

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Charlotte, North Carolina, 28204, United States

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Charlotte, North Carolina, 28210, 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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Salisbury, North Carolina, 28144, United States

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Wilmington, North Carolina, 28412, United States

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Winston-Salem, North Carolina, 27103, 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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Maumee, Ohio, 43537, United States

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Oklahoma City, Oklahoma, 73112, United States

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Eugene, Oregon, 97404, 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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GSK Investigational Site

Portland, Oregon, 97210, United States

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GSK Investigational Site

Portland, Oregon, 97225, United States

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GSK Investigational Site

Portland, Oregon, 97232, United States

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GSK Investigational Site

Bala-Cynwyd, Pennsylvania, 19004, United States

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Nazareth, Pennsylvania, 18064, United States

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Whitehall, Pennsylvania, 18052, United States

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Wyomissing, Pennsylvania, 19610, United States

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Warwick, Rhode Island, 02886, United States

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Woonsocket, Rhode Island, 02895, United States

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Charleston, South Carolina, 29406, United States

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GSK Investigational Site

Murrells Inlet, South Carolina, 29576, United States

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Spartanburg, South Carolina, 29303, United States

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Arlington, Texas, 76017, United States

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Brownwood, Texas, 76801, United States

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Colleyville, Texas, 76034, United States

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Galveston, Texas, 77555, United States

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Houston, Texas, 77054, United States

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GSK Investigational Site

Houston, Texas, 77074, United States

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Lake Jackson, Texas, 77566, United States

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San Antonio, Texas, 78205, United States

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San Antonio, Texas, 78238, United States

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Alexandria, Virginia, 22304, United States

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Chesapeake, Virginia, 23322, United States

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Christiansburg, Virginia, 24073, United States

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Danville, Virginia, 24541, 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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Lacey, Washington, 98516, United States

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Spokane, Washington, 99204, United States

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Vienna, A-1100, Austria

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Vienna, A-1130, Austria

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Edmonton, Alberta, T5A 4L8, 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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St. John's, Newfoundland and Labrador, A1B 3E1, Canada

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Halifax, Nova Scotia, B3K 5R3, Canada

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Brampton, Ontario, L6T 3J1, Canada

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Kitchener, Ontario, N2M 5N6, Canada

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Toronto, Ontario, M9W 4L6, Canada

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Chandler, Quebec, G0C 1K0, Canada

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Mirabel, Quebec, J7J 2K8, Canada

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Montreal, Quebec, H3M 3A9, Canada

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Sherbrooke, Quebec, J1H 1Z1, Canada

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Hvidovre, 2650, Denmark

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Ishøj, 2635, Denmark

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Odense C, 5000, Denmark

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Tallinn, 10617, Estonia

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GSK Investigational Site

Helsinki, 00029, Finland

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Fellbach, Baden-Wurttemberg, 70736, Germany

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Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

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Villingen-Schwenningen, Baden-Wurttemberg, 78054, Germany

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Weinheim, Baden-Wurttemberg, 69469, Germany

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Augsburg, Bavaria, 86150, Germany

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Nuremberg, Bavaria, 90402, Germany

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Hamburg, Hamburg, 20249, Germany

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Hamburg, Hamburg, 22149, Germany

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Hamburg, Hamburg, 22525, Germany

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Hüttenberg, Hesse, 35625, Germany

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Wiesbaden, Hesse, 65195, Germany

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Schwerin, Mecklenburg-Vorpommern, 19055, Germany

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Cologne, North Rhine-Westphalia, 50924, Germany

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Cologne, North Rhine-Westphalia, 51069, Germany

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Essen, North Rhine-Westphalia, 45359, Germany

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Viersen, North Rhine-Westphalia, 41749, Germany

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Witten, North Rhine-Westphalia, 58455, Germany

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Chemnitz, Saxony, 09111, Germany

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Dresden, Saxony, 01307, Germany

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Kiel, Schleswig-Holstein, 24105, Germany

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Pinneberg, Schleswig-Holstein, 25421, Germany

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Berlin, State of Berlin, 10115, Germany

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GSK Investigational Site

Berlin, State of Berlin, 10117, Germany

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GSK Investigational Site

Berlin, State of Berlin, 10409, Germany

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Berlin, State of Berlin, 10435, Germany

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Berlin, State of Berlin, 13125, Germany

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Cork, Ireland

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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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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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Glasgow, Lanarkshire, G3 8YJ, United Kingdom

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Glasgow, Lanarkshire, G69 7AD, United Kingdom

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Blackpool, Lancashire, FY4 3AD, United Kingdom

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Ashford, Middlesex, TW15 3EA, United Kingdom

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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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Leeds, LS14 6UH, United Kingdom

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London, SE5 9RS, United Kingdom

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Yaxley, Peterborough, PE7 3JL, United Kingdom

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York, YO31 8HE, United Kingdom

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Related Publications (1)

• 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.

  PMID: 21292169 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 21, 2005
• First Posted: November 22, 2005
• Study Start: August 1, 2005
• Study Completion: May 1, 2006
• Last Updated: September 2, 2015

Record last verified: 2011-12

Locations

CA (12); FI (1); DE (26); ES (1); DK (3); GB (14); AU (2); IE (1); PL (3); US (137)