Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
NCT ID: NCT01323790
Last Updated: 2015-06-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
700 participants
INTERVENTIONAL
2011-03-31
2012-09-30
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
TRIPLE
Study Groups
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1
Oral treatment
NKTR-118
12.5 mg oral tablet once daily
2
Oral treatment
NKTR-118
25 mg oral tablet once daily
3
Oral treatment
Placebo
Placebo to NKTR-118
Interventions
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NKTR-118
12.5 mg oral tablet once daily
NKTR-118
25 mg oral tablet once daily
Placebo
Placebo to NKTR-118
Eligibility Criteria
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Inclusion Criteria
* Self-reported active symptoms of OIC at screening (\<3 SBMs/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 SBMs/week on average over the 2-week OIC confirmation period.
* Receiving a stable maintenance opioid regimen consisting of a total daily dose of 30 mg to 1000 mg of oral morphine, or equianalgesic amount(s) of 1 or more other opioid therapies for a minimum of 4 weeks prior to screening for non-cancer-related pain with no anticipated change in opioid dose requirement over the proposed study period as a result of disease progression.
* Willingness to stop all laxatives and other bowel regimens including prune juice and herbal products throughout the 2-week OIC confirmation period and the 12-week treatment period, and to use only bisacodyl as rescue medication if a BM has not occurred within at least 72 hours of the last recorded BM.
Exclusion Criteria
* History of cancer within 5 years from first study visit with the exception of basal cell cancer and squamous cell skin cancer.
* Medical conditions and treatments associated with diarrhea, intermittent loose stools, or constipation.
* Other issues to the gastrointestinal tract that could impose a risk to the patient.
* Pregnancy or lactation.
18 Years
84 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Sostek
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Mobile, Alabama, United States
Research Site
Pell City, Alabama, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Sun Lakes, Arizona, United States
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Tucson, Arizona, United States
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Jonesboro, Arkansas, United States
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Little Rock, Arkansas, United States
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North Little Rock, Arkansas, United States
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Sherwood, Arkansas, United States
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Chino, California, United States
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La Jolla, California, United States
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Lincoln, California, United States
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Modesto, California, United States
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Colorado Springs, Colorado, United States
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Stamford, Connecticut, United States
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Bradenton, Florida, United States
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Delray Beach, Florida, United States
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Gainesville, Florida, United States
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Miami, Florida, United States
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Miami Springs, Florida, United States
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Ocala, Florida, United States
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Sanford, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Conyers, Georgia, United States
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John's Creek, Georgia, United States
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Peoria, Illinois, United States
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Council Bluffs, Iowa, United States
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Wichita, Kansas, United States
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Baton Rouge, Louisiana, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Chestnut Hill, Massachusetts, United States
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Watertown, Massachusetts, United States
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Livonia, Michigan, United States
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Saint Clair Shores, Michigan, United States
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Florissant, Missouri, United States
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Henderson, Nevada, United States
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Freehold, New Jersey, United States
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Voorhees Township, New Jersey, United States
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Willingboro, New Jersey, United States
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Great Neck, New York, United States
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Hartsdale, New York, United States
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North Massapequa, New York, United States
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Chapel Hill, North Carolina, United States
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Morrisville, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Bellevue, Ohio, United States
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Downingtown, Pennsylvania, United States
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Jenkintown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pottstown, Pennsylvania, United States
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Anderson, South Carolina, United States
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Myrtle Beach, South Carolina, United States
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Chattanooga, Tennessee, United States
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Jackson, Tennessee, United States
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Milan, Tennessee, United States
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Austin, Texas, United States
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Houston, Texas, United States
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Hurst, Texas, United States
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Marshall, Texas, United States
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San Antonio, Texas, United States
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Sugarland, Texas, United States
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Clinton, Utah, United States
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St. George, Utah, United States
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West Jordan, Utah, United States
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Edegem, Belgium, Belgium
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Roeselare, Belgium, Belgium
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Antwerp, , Belgium
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Leuven, , Belgium
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Moerkerke, , Belgium
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Mouscron, , Belgium
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Bjelovar, , Croatia
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Osijek, , Croatia
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Susak, , Croatia
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Zagreb, , Croatia
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Choceň, , Czechia
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Pardubice, , Czechia
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Prague, , Czechia
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Zlín, , Czechia
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Baja, , Hungary
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Budapest, , Hungary
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Kecskemét, , Hungary
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Miskolc, , Hungary
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Pusztaszer, , Hungary
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Sátoraljaújhely, , Hungary
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Szeged, , Hungary
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Szikszó, , Hungary
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Úrhida, , Hungary
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Zalaegerszeg, , Hungary
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Málaga, Andalusia, Spain
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Barcelona, Catalonia, Spain
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Centelles (barcelona), Catalonia, Spain
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L'Hospitalet de Llobregat, Catalu?a, Spain
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Vic, Catalu?a, Spain
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Fuenlabrada, Madrid, Spain
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Almería, , Spain
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Lleida, , Spain
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Madrid, , Spain
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Santiago de Compostela, , Spain
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Valencia, , Spain
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Valladolid, , Spain
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Gothenburg, , Sweden
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Lund, , Sweden
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Stockholm, , Sweden
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Vällingby, , Sweden
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Ayrshire, AYR, United Kingdom
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Chesterfield, Derby, United Kingdom
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Derby, Derby, United Kingdom
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Plymouth, Devon, United Kingdom
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London, Gt Lon, United Kingdom
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Royton, Lancashire, United Kingdom
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Thornton-Cleveleys, Lancashire, United Kingdom
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Norwich, Norflk, United Kingdom
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Barry, S Glam, United Kingdom
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Bath, Somer, United Kingdom
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Glasgow, Strath, United Kingdom
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Coventry, Warwks, United Kingdom
Countries
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References
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Lawson R, King F, Marsh K, Altincatal A, Cimen A. Impact of Treatment with Naloxegol for Opioid-Induced Constipation on Patients' Health State Utility. Adv Ther. 2016 Aug;33(8):1331-46. doi: 10.1007/s12325-016-0365-y. Epub 2016 Jun 24.
Tack J, Lappalainen J, Diva U, Tummala R, Sostek M. Efficacy and safety of naloxegol in patients with opioid-induced constipation and laxative-inadequate response. United European Gastroenterol J. 2015 Oct;3(5):471-80. doi: 10.1177/2050640615604543.
Chey WD, Webster L, Sostek M, Lappalainen J, Barker PN, Tack J. Naloxegol for opioid-induced constipation in patients with noncancer pain. N Engl J Med. 2014 Jun 19;370(25):2387-96. doi: 10.1056/NEJMoa1310246. Epub 2014 Jun 4.
Related Links
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Clinical Study Protocol
Clinical\_Study\_Report\_Synopsis\_D3820C00005
Other Identifiers
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2011-001986-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D3820C00005
Identifier Type: -
Identifier Source: org_study_id
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