Study Of Alvimopan Drug For Treatment Of Constipation Due To Prescription Pain Medication

NCT00101998 | Completed Phase 2

• 2 other identifiers: 3753-009767905/008
• Study Type: interventional
• Target: 233
• Locations: 26 countries
• Sites: 162

Brief Summary

A multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in subjects with cancer pain. The study will require five visits over a five-week period.

Conditions

Constipation; Bowel Dysfunction

Keywords

OBD (Induced Bowel Dysfunction); cancer pain; pain medication; constipation; bowel; bowel dysfunction

Outcome Measures

Primary Outcomes (1)

• Change in weekly SCBM frequency. A SCBM is a spontaneous and complete bowel movement, which means a bowel movement that occurs with no laxative use in the prior 24 hours and leaves the subject with the feeling of complete evacuation of the rectum.

Secondary Outcomes (1)

• Additional measures of Bowel movement (BM) frequency and symptoms, safety profile of the treatment regimens and any changes in pain intensity or opioid use.

Study Arms (4)

Alvimopan 0.5 mg Twice Daily (BID)

EXPERIMENTAL

0.5 milligrams (mg) of alvimopan was administered orally BID for 3 weeks.

Drug: alvimopan

Alvimopan 1 mg Once Daily (QD)

EXPERIMENTAL

0.5 mg of alvimopan was administered orally QD for 3 days, then 1 mg of alvimopan QD for the remaining 3 weeks. Placebo was administered orally QD to maintain the blind. A protocol amendment dropped this arm because another study had demonstrated 1 mg QD treatment to have similar efficacy but a less favorable gastrointestinal-related safety profile compared with 0.5 mg BID treatment.

Drug: alvimopan; Drug: placebo

Alvimopan 1 mg Twice Daily (BID)

EXPERIMENTAL

0.5 mg of alvimopan was administered orally BID for 3 days, then 1 mg of alvimopan BID for the remaining 3 weeks.

Drug: alvimopan

Placebo

PLACEBO COMPARATOR

Placebo was administered orally BID for 3 weeks.

Drug: placebo

Interventions

alvimopan DRUG

Alvimopan 0.5 mg Twice Daily (BID); Alvimopan 1 mg Once Daily (QD); Alvimopan 1 mg Twice Daily (BID)

placebo DRUG

Alvimopan 1 mg Once Daily (QD); Placebo

Eligibility Criteria

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

You may qualify if:

• Participant is in any stage of cancer but has a minimum life expectancy of at least 3 months at the time of the Screening Visit.
• Participant is taking opioid therapy for persistent cancer pain.
• Participant meets the definition of opioid-induced bowel dysfunction as follows: Since starting opioid therapy, the subject has had decreased bowel movement (BM) frequency and at least one of the following constipation symptoms \[sensation of incomplete evacuation, difficulty in expelling stool (straining), hard stools (abnormal stool consistency)\].
• Participant understands the procedures, agrees to participate in the study, and has signed and dated the informed consent form prior to the initiation of any study-related activities, including discontinuation of pre-study laxative regimen or other prohibited medications.
• Participant is able and willing to comply with a daily paper diary and is capable of completing paper questionnaires at study visits.

You may not qualify if:

• Participant is pregnant or lactating, or planning to become pregnant.
• Participant is not ambulatory.
• Participant has participated in another trial with an investigational drug (unapproved), device or procedure within 30 days of the Screening Visit.
• Participant is unable to eat, drink, take/hold down oral medications.
• Participant is taking opioids for the management of drug addiction.
• Participant is unable or unwilling to discontinue the use of and/or refrain from using laxatives of all types and formulation at the Screening Visit and throughout the entire study.
• Participant has severe constipation that has not been appropriately managed such that the subject is at immediate risk of developing serious complications of constipation. This would include a subject who has reported no bowel movement for 7 consecutive days prior to the Screening Visit.
• Participant with gastrointestinal or pelvic disorders known to affect bowel transit, produce gastrointestinal (GI) obstruction, or contribute to bowel dysfunction.
• Participant is currently taking vinca alkyloids or plans to take vinca alkyloids during the study.
• Participant is currently undergoing abdominal radiation therapy and/or plans to undergo abdominal radiation therapy during the study.
• Participant is human immunodeficiency virus (HIV)-infected, has active hepatitis (any subtype including ongoing chronic hepatitis B), 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 (162)

GSK Investigational Site

Tucson, Arizona, 85723, United States

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Hot Springs, Arkansas, 71913, 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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Fresno, California, 93720, United States

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La Verne, California, 91750, United States

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Los Angeles, California, 90057, United States

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Los Gatos, California, 95032, United States

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Modesto, California, 95355, United States

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Sacramento, California, 95819, United States

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San Diego, California, 92103, United States

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San Diego, California, 92120, United States

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Santa Monica, California, 90403, United States

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Denver, Colorado, 80210, United States

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Washington D.C., District of Columbia, 20007, United States

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Washington D.C., District of Columbia, 20010, United States

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Gainesville, Florida, 32604, United States

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Inverness, Florida, 34452, United States

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Lecanto, Florida, 34461, United States

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Miami Shores, Florida, 33138, United States

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New Port Richey, Florida, 34652, United States

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New Port Richey, Florida, 34653, United States

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Ocala, Florida, 34474, United States

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Palm Harbor, Florida, 34684, United States

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Stuart, Florida, 34996, United States

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Tampa, Florida, 33612-9497, United States

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Titusville, Florida, 32796, United States

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Decatur, Georgia, 30033, United States

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Chicago, Illinois, 60610, United States

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West Des Moines, Iowa, 50265, United States

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Hutchinson, Kansas, 67502, United States

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Baltimore, Maryland, 21218, United States

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Baltimore, Maryland, 21229-5299, United States

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Baltimore, Maryland, 21239, United States

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Bethesda, Maryland, 20817, United States

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Boston, Massachusetts, 02115, United States

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Boston, Massachusetts, 02215, United States

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Worcester, Massachusetts, 01608, United States

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Ann Arbor, Michigan, 48109, United States

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Flint, Michigan, 48503, United States

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Saint Louis Park, Minnesota, 55426, United States

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Kansas City, Missouri, 64114, United States

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St Louis, Missouri, 63141, United States

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Reno, Nevada, 89502, United States

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Albuquerque, New Mexico, 87109, United States

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Bethpage, New York, 11714, United States

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Huntington Station, New York, 11746, United States

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Jamaica, New York, 11432, United States

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Chapel Hill, North Carolina, 27599, United States

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Charlotte, North Carolina, 28209, United States

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Durham, North Carolina, 27710, United States

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Hendersonville, North Carolina, 28793, United States

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Raleigh, North Carolina, 27606, United States

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Winston-Salem, North Carolina, 27103, United States

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Bismarck, North Dakota, 58501, United States

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Bismarck, North Dakota, 58503, United States

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Canton, Ohio, 44718, United States

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Middletown, Ohio, 45042, United States

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Portland, Oregon, 97225, United States

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Nashville, Tennessee, 37232, United States

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Amarillo, Texas, 79106, United States

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Houston, Texas, 77030, United States

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Webster, Texas, 77598, United States

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Norfolk, Virginia, 23507, United States

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Portsmouth, Virginia, 23704, United States

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Richmond, Virginia, 23249, United States

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Richmond, Virginia, 23298-5028, United States

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Tacoma, Washington, 98405, United States

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Milwaukee, Wisconsin, 53215, United States

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Capital Federal, Buenos Aires, C1405CUB, Argentina

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Rosario, Santa Fe Province, 2000, Argentina

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St Leonards, New South Wales, 2065, Australia

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Redcliffe, Queensland, 4020, Australia

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South Brisbane, Queensland, 4101, Australia

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Daw Park, South Australia, 5041, Australia

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Malvern, Victoria, 3144, Australia

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Winnipeg, Manitoba, R3A 1R9, Canada

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St. John's, Newfoundland and Labrador, A1B 3V6, Canada

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Greater Sudbury, Ontario, P3E 5J1, Canada

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Kitchener, Ontario, N2G 1G3, Canada

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London, Ontario, N6A 4L6, Canada

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North Bay, Ontario, P1B 2H3, Canada

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Oshawa, Ontario, L1G 2B9, Canada

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Bonaventure, Quebec, G0C 1E0, Canada

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Chandler, Quebec, G0C 1K0, Canada

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Lévis, Quebec, G6V 3Z1, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Sherbrooke, Quebec, J1H 1Z1, Canada

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Québec, G1R 2J6, Canada

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Brno, 625 00, Czechia

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Brno, 656 91, Czechia

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Pilsen, 304 60, Czechia

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Prague, 100 34, Czechia

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Helsinki, 00029, Finland

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Bordeaux, 33076, France

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Vandœuvre-lès-Nancy, 54511, France

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Villejuif, 94805, France

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Goslar, Lower Saxony, 38642, Germany

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Göttingen, Lower Saxony, 37073, Germany

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Kwun Tong, Hong Kong

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Pokfulam, Hong Kong

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Shatin, Hong Kong

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Budapest, 1097, Hungary

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Budapest, 1529, Hungary

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Miskolc, 3529, Hungary

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Zalaegerszeg-Pozva, 8900, Hungary

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Bangalore, 560 034, India

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Caserta, Campania, 81100, Italy

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Napoli, Campania, 80131, Italy

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Forlì, Emilia-Romagna, 47100, Italy

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Rimini, Emilia-Romagna, 47900, Italy

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Genoa, Liguria, 16132, Italy

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Milan, Lombardy, 20127, Italy

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Pavia, Lombardy, 27100, Italy

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Busca (CN), Piedmont, 12022, Italy

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Novara, Piedmont, 28100, Italy

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Catania, Sicily, 95124, Italy

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Florence, Tuscany, 50139, Italy

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Leeuwarden, 8934 AD, Netherlands

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Dunedin, 9001, New Zealand

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Hastings, 4201, New Zealand

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Wellington, 6002, New Zealand

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Lahore, 54600, Pakistan

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Lima, Lima 11, Peru

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Lima, Lima 34, Peru

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Manila, 1000, Philippines

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Bialystok, 15-540, Poland

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Olsztyn, 10-228, Poland

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Otwock, 05-400, Poland

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Poznan, 60-569, Poland

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Lisbon, 1069-166 Lisboa, Portugal

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Lisbon, 1070, Portugal

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Lisbon, 1800, Portugal

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Moscow, 117216, Russia

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Moscow, 119048, Russia

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Moscow, 127018, Russia

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St'Petersburg, 195247, Russia

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Durban, KwaZulu-Natal, 4001, South Africa

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Groenkloof, Pretoria, South Africa

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Houghton, Johannesburg, 2000, South Africa

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Kenilworth, Cape Town, 7745, South Africa

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Seoul, 137-701, South Korea

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Seoul, 152-703, South Korea

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Alcorcón, 28922, Spain

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Barcelona, 08023, Spain

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Barcelona, 08036, Spain

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Córdoba, 14004, Spain

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Granada, 18012, Spain

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Jaén, 23007, Spain

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Madrid, 28006, Spain

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Sabadell / Barcelona, Spain

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Serra / Valencia, Spain

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Seville, 41014, Spain

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Soria, 42002, Spain

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Valencia, 46010, Spain

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Taipei, 100, Taiwan

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Chiang Mai, 50200, Thailand

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London, SW3 6JJ, United Kingdom

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Newcastle upon Tyne, NE4 6BE, United Kingdom

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Nottingham, NG5 1PB, United Kingdom

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Sheffield, S10 2JF, United Kingdom

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Surrey, SM2 5PT, United Kingdom

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MeSH Terms

Conditions

Constipation; Intestinal Diseases; Cancer Pain

Interventions

alvimopan

Condition Hierarchy (Ancestors)

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

Study Officials

• GSK Clinical Trials, MD

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2005
• First Posted: January 19, 2005
• Study Start: October 1, 2003
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: August 30, 2017

Record last verified: 2017-08

Locations

PT (3); ZA (4); ES (12); PA (1); FI (1); KR (2); TH (1); NL (1); GB (5); US (69); DE (2); HU (4); IT (11); AR (2); AU (5); TW (1); NZ (3); FR (3); CZ (4); HK (3); CA (13); PH (1); PL (4); RU (4); PE (2); IN (1)