Study Of Alvimopan Drug For Treatment Of Constipation Due To Prescription Pain Medication
NCT ID: NCT00101998
Last Updated: 2017-08-30
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
PHASE2
233 participants
INTERVENTIONAL
2003-10-01
2006-05-01
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
DOUBLE
Study Groups
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Alvimopan 0.5 mg Twice Daily (BID)
0.5 milligrams (mg) of alvimopan was administered orally BID for 3 weeks.
alvimopan
Alvimopan 1 mg Once Daily (QD)
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.
alvimopan
placebo
Alvimopan 1 mg Twice Daily (BID)
0.5 mg of alvimopan was administered orally BID for 3 days, then 1 mg of alvimopan BID for the remaining 3 weeks.
alvimopan
Placebo
Placebo was administered orally BID for 3 weeks.
placebo
Interventions
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alvimopan
placebo
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
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
Tucson, Arizona, United States
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Hot Springs, Arkansas, United States
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Duarte, California, United States
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Fountain Valley, California, United States
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Fresno, California, United States
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La Verne, California, United States
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Los Angeles, California, United States
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Los Gatos, California, United States
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Modesto, California, United States
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Sacramento, 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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Santa Monica, California, United States
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Denver, Colorado, United States
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Washington D.C., District of Columbia, United States
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Washington D.C., District of Columbia, United States
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Gainesville, Florida, United States
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Inverness, Florida, United States
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Lecanto, Florida, United States
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Miami Shores, Florida, United States
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New Port Richey, Florida, United States
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New Port Richey, Florida, United States
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Ocala, Florida, United States
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Palm Harbor, Florida, United States
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Stuart, Florida, United States
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Tampa, Florida, United States
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Titusville, Florida, United States
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Decatur, Georgia, United States
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Chicago, Illinois, United States
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West Des Moines, Iowa, United States
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Hutchinson, Kansas, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Baltimore, Maryland, United States
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Bethesda, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Worcester, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Flint, Michigan, United States
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Saint Louis Park, Minnesota, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Reno, Nevada, United States
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Albuquerque, New Mexico, United States
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Bethpage, New York, United States
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Huntington Station, New York, United States
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Jamaica, New York, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Hendersonville, North Carolina, United States
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Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Bismarck, North Dakota, United States
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Bismarck, North Dakota, United States
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Canton, Ohio, United States
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Middletown, Ohio, United States
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Portland, Oregon, United States
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Nashville, Tennessee, United States
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Amarillo, Texas, United States
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Houston, Texas, United States
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Webster, Texas, United States
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Norfolk, Virginia, United States
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Portsmouth, Virginia, United States
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Richmond, Virginia, United States
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Richmond, Virginia, United States
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Tacoma, Washington, United States
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Milwaukee, Wisconsin, United States
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Capital Federal, Buenos Aires, Argentina
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Rosario, Santa Fe Province, Argentina
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St Leonards, New South Wales, Australia
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Redcliffe, Queensland, Australia
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South Brisbane, Queensland, Australia
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Daw Park, South Australia, Australia
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Malvern, Victoria, Australia
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Winnipeg, Manitoba, Canada
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St. John's, Newfoundland and Labrador, Canada
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Greater Sudbury, Ontario, Canada
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Kitchener, Ontario, Canada
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London, Ontario, Canada
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North Bay, Ontario, Canada
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Oshawa, Ontario, Canada
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Bonaventure, Quebec, Canada
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Chandler, Quebec, Canada
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Lévis, Quebec, Canada
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Montreal, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Québec, , Canada
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Brno, , Czechia
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Brno, , Czechia
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Pilsen, , Czechia
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Prague, , Czechia
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Helsinki, , Finland
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Bordeaux, , France
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Vandœuvre-lès-Nancy, , France
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Villejuif, , France
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Goslar, Lower Saxony, Germany
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Göttingen, Lower Saxony, 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, , Hungary
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Budapest, , Hungary
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Miskolc, , Hungary
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Zalaegerszeg-Pozva, , Hungary
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Bangalore, , India
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Caserta, Campania, Italy
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Napoli, Campania, Italy
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Forlì, Emilia-Romagna, Italy
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Rimini, Emilia-Romagna, Italy
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Genoa, Liguria, Italy
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Milan, Lombardy, Italy
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Pavia, Lombardy, Italy
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Busca (CN), Piedmont, Italy
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Novara, Piedmont, Italy
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Catania, Sicily, Italy
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Florence, Tuscany, Italy
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Leeuwarden, , Netherlands
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Dunedin, , New Zealand
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Hastings, , New Zealand
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Wellington, , New Zealand
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Lahore, , Pakistan
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Lima, , Peru
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Lima, , Peru
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Manila, , Philippines
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Bialystok, , Poland
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Olsztyn, , Poland
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Otwock, , Poland
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Poznan, , Poland
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Lisbon, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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St'Petersburg, , Russia
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Durban, KwaZulu-Natal, South Africa
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Groenkloof, Pretoria, , South Africa
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Houghton, Johannesburg, , South Africa
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Kenilworth, Cape Town, , South Africa
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Seoul, , South Korea
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Seoul, , South Korea
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Alcorcón, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Córdoba, , Spain
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Granada, , Spain
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Jaén, , Spain
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Madrid, , Spain
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Sabadell / Barcelona, , Spain
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Serra / Valencia, , Spain
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Seville, , Spain
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Soria, , Spain
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Valencia, , Spain
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Taipei, , Taiwan
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Chiang Mai, , Thailand
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London, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Nottingham, , United Kingdom
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Sheffield, , United Kingdom
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Surrey, , United Kingdom
Countries
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Other Identifiers
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767905/008
Identifier Type: OTHER
Identifier Source: secondary_id
3753-009
Identifier Type: -
Identifier Source: org_study_id
NCT00903513
Identifier Type: -
Identifier Source: nct_alias
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