Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related Pain
NCT ID: NCT01384292
Last Updated: 2015-06-01
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
14 participants
INTERVENTIONAL
2011-06-30
2012-09-30
Brief Summary
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The study consists of 2 parts; A initial 4-week treatment period (part A) and then a 12 week extension with active treatment (part B).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1 (part A and B)
Oral treatment
NKTR-118
12.5 mg oral tablet once daily
2 (part A and B)
Oral treatment
NKTR-118
25 mg oral tablet once daily
3 (part A only)
Oral treatment
Placebo
Oral treatment
Interventions
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NKTR-118
12.5 mg oral tablet once daily
NKTR-118
25 mg oral tablet once daily
Placebo
Oral treatment
Eligibility Criteria
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Inclusion Criteria
* Men and women aged 18 or older.
* Histologically or cytologically confirmed neoplasm causing pain and requiring management with opioids.
* Self-reported active symptoms of OIC at screening (\<3 RFBMs/week and experiencing \>1 reported symptom of hard/lumpy stools, straining, or sensation of incomplete evacuation/anorectal obstruction in at least 25% of BMs over the previous 4 weeks); and Documented confirmed OIC (\<3 RFBMs/week on average aver the 2-week OIC confirmation period.
* Receiving a stable maintenance opioid regimen consisting of a total daily dose of \>30 mg of oral morphine, or equianalgesic amount(s) of 1 or more opioid therapies for a minimum of 4 weeks prior to screening for cancer-related pain with no anticipated change in opioid dose requirement over the proposed study period as a result of disease progression.
Exclusion Criteria
* Any condition that may have affected the permeability of the blood-brain barrier, eg, known brain metastases, meningeal metastases, brain injury, multiple sclerosis, recent brain injury, uncontrolled epilepsy.
* Patients with cancer-related pain due to ovarian cancer, leukaemia, or lymphoma are excluded. Patients with multiple myeloma will be allowed.
* Patients requiring radiation therapy between the diaphragm and pelvis 4 weeks prior to Visit 1 (screening) and/or during Part A of the study are excluded. Any patients with suspected clinically relevant radiation-induced injury of small or large intestine are excluded.
* Pregnancy or lactation.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Huntsville, Alabama, United States
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Casa Grande, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Fort Smith, Arkansas, United States
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Hot Springs, Arkansas, United States
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North Little Rock, Arkansas, United States
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Encino, California, United States
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Fountain Valley, California, United States
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Gilroy, California, United States
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Laguna Hills, California, United States
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Montebello, California, United States
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Orange, California, United States
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Riverside, California, United States
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San Bernardino, California, United States
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Aurora, Colorado, United States
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Denver, Colorado, United States
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Baypines, Florida, United States
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Boynton Beach, Florida, United States
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Celebration, Florida, United States
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Clearwater, Florida, United States
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Coral Gables, Florida, United States
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Hialeah, Florida, United States
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Jacksonville, Florida, United States
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Lake Worth, Florida, United States
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Lakeland, Florida, United States
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Miami, Florida, United States
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Miami Lakes, Florida, United States
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Naples, Florida, United States
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Plantation, Florida, United States
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Tavares, Florida, United States
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Albany, Georgia, United States
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Marietta, Georgia, United States
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Riverdale, Georgia, United States
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Roswell, Georgia, United States
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Honolulu, Hawaii, United States
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Chicago, Illinois, United States
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Springfield, Illinois, United States
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Anderson, Indiana, United States
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Evansville, Indiana, United States
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Owensboro, Kentucky, United States
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Lafayette, Louisiana, United States
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Elkridge, Maryland, United States
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Hollywood, Maryland, United States
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Boston, Massachusetts, United States
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Fairhaven, Massachusetts, United States
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Detroit, Michigan, United States
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Kalamazoo, Michigan, United States
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Southaven, Mississippi, United States
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Jefferson City, Missouri, United States
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St Louis, Missouri, United States
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Missoula, Montana, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Toms River, New Jersey, United States
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Voorhees Township, New Jersey, United States
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Great Neck, New York, United States
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Syracuse, New York, United States
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Chapel Hill, North Carolina, United States
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Flat Rock, North Carolina, United States
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Morrisville, North Carolina, United States
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Wilmington, 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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Akron, Ohio, United States
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Beavercreek, Ohio, United States
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Cleveland, Ohio, United States
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Middleton, Ohio, United States
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Danville, Pennsylvania, United States
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East Providence, Rhode Island, United States
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Charleston, South Carolina, United States
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Chattanooga, Tennessee, United States
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Beaumont, Texas, United States
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Bellaire, Texas, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Lubbock, Texas, United States
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San Antonio, Texas, United States
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Sugarland, Texas, United States
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Fairfax, Virginia, United States
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Broadmeadow, New South Wales, Australia
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Frankston, Victoria, Australia
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Malvern, Victoria, Australia
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Parkville, Victoria, Australia
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Fremantle, Western Australia, Australia
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Edegem, Belgium, Belgium
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Mons, Belgium, Belgium
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Brussels, , Belgium
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Wetteren, , Belgium
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Haskovo, , Bulgaria
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Pleven, , Bulgaria
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Rousse, , Bulgaria
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Shumen, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Zagreb, , Croatia
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Benešov, , Czechia
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České Budějovice, , Czechia
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Prague, , Czechia
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Hamburg, City state of Hamburg, Germany
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Wiesbaden, Hesse, Germany
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Berlin, State of Berlin, Germany
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Offenbach, , Germany
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Brzozów, , Poland
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Bydgoszcz, , Poland
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Gdansk, , Poland
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Gliwice, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Ponce, , Puerto Rico
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Craiova, Dolj, Romania
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Ploieşti, Prahova, Romania
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Baia Mare, , Romania
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Brasov, , Romania
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Brăila, , Romania
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Onești, , Romania
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Bardejov, , Slovakia
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Bratislava, , Slovakia
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Košice, , Slovakia
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Prešov, , Slovakia
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Port Elizabeth, Eastern Cape, South Africa
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Bloemfontein, Free State, South Africa
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Benoni, Gauteng, South Africa
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Pretoria, Gauteng, South Africa
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Vereeniging, Gauteng, South Africa
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Durban, Kz-natal, South Africa
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Goodwood, W Cape, South Africa
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Seville, Andalusia, Spain
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A Coruña, Galicia, Spain
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Valencia, Valencia, Spain
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Penarth, CRF, United Kingdom
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Norwich, Norfolk, United Kingdom
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Guildford, Surrey, United Kingdom
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Chippenham, Wilts, United Kingdom
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Coventry, , United Kingdom
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London, , United Kingdom
Countries
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Related Links
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Clinical\_Study\_Report\_Synopsis\_D3820C00006
Other Identifiers
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2011-001985-16
Identifier Type: -
Identifier Source: secondary_id
D3820C00006
Identifier Type: -
Identifier Source: org_study_id
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