Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
NCT ID: NCT01309841
Last Updated: 2015-06-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
652 participants
INTERVENTIONAL
2011-03-31
2012-08-31
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
Oral tablet once daily
Interventions
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NKTR-118
12.5 mg oral tablet once daily
NKTR-118
25 mg oral tablet once daily
Placebo
Oral tablet once daily
Eligibility Criteria
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Inclusion Criteria
* Men and women who are between the ages of ≥18 and \<85 years.
* 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 Pharmaceuticals, Wilm DE
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Calera, Alabama, United States
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Glendale, Arizona, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Hot Springs, Arkansas, United States
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Malvern, Arkansas, United States
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Anaheim, California, United States
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Beverly Hills, California, United States
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Burbank, California, United States
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Garden Grove, California, United States
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Laguana Hills, California, United States
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Laguna Hills, California, United States
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Long Beach, California, United States
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Los Gatos, California, United States
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Montebello, California, United States
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National City, California, United States
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Norwalk, California, United States
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Paramount, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Santa Ana, California, United States
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Denver, Colorado, United States
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Boynton Beach, Florida, United States
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Brooksville, Florida, United States
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DeLand, Florida, United States
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Fort Myers, Florida, United States
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Hialeah, Florida, United States
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Inverness, Florida, United States
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Jacksonville, Florida, United States
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Jackson, Florida, United States
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Jupiter, Florida, United States
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Maitland, Florida, United States
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Miami, Florida, United States
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Naples, Florida, United States
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Orlando, Florida, United States
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Ormond Beach, Florida, United States
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Pembroke Pines, Florida, United States
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Plantation, Florida, United States
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Tamarac, Florida, United States
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Tampa, Florida, United States
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Venice, Florida, United States
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West Palm Beach, Florida, United States
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Winter Park, Florida, United States
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Atlanta, Georgia, United States
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Decatur, Georgia, United States
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Boise, Idaho, United States
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Bloomington, Illinois, United States
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Rockford, Illinois, United States
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Evansville, Indiana, United States
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Greenfield, Indiana, United States
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Indianapolis, Indiana, United States
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West Des Moines, Iowa, United States
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Pikesville, Maryland, United States
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Brockton, Massachusetts, United States
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Kalamazoo, Michigan, United States
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Biloxi, Mississippi, United States
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Saint Joseph, 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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Trenton, New Jersey, United States
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Albuquerque, New Mexico, United States
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New York, New York, United States
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Charlotte, North Carolina, United States
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Greensboro, North Carolina, United States
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Hickory, North Carolina, United States
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High Point, North Carolina, United States
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Morrisville, North Carolina, United States
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Beavercreek, Ohio, United States
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Cincinnati, Ohio, United States
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Medord, Oregon, United States
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Feasterville, Pennsylvania, United States
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Huntingdon Valley, Pennsylvania, United States
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Levittown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Yardley, Pennsylvania, United States
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Cumberland, Rhode Island, United States
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Charleston, South Carolina, United States
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Greer, South Carolina, United States
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Orangeburg, South Carolina, United States
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Clarksville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Doral, Texas, United States
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Houston, Texas, United States
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North Richland Hills, Texas, United States
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Salt Lake City, Utah, United States
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Spokane, Washington, United States
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Broadmeadow, New South Wales, Australia
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Darlinghurst, New South Wales, Australia
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Port Kembla, New South Wales, Australia
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Westmead, New South Wales, Australia
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Greenslopes, Queensland, Australia
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Adelaide, South Australia, Australia
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Fremantle, Western Australia, Australia
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Nedlands, Western Australia, Australia
Research Site
Potsdam, BR, Germany
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Hamburg, City state of Hamburg, Germany
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Dietzenbach, Hesse, Germany
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Hüttenberg, Hesse, Germany
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Wetzlar, Hesse, Germany
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Celle, Lower Saxony, Germany
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Hanover, Lower Saxony, Germany
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Schwerin, Mecklenburg-Vorpommern, Germany
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Essen, North Rhine-Westphalia, Germany
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Mainz, Rhineland-Palatinate, Germany
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Dresden, Saxony, Germany
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Leipzig, Saxony, Germany
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Kiel, Schleswig-Holstein, Germany
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Berlin, State of Berlin, Germany
Research Site
Banská Bystrica, , Slovakia
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Bratislava, , Slovakia
Research Site
Košice, , Slovakia
Research Site
Prešov, , Slovakia
Countries
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References
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Webster L, Tummala R, Diva U, Lappalainen J. A 12-week extension study to assess the safety and tolerability of naloxegol in patients with noncancer pain and opioid-induced constipation. J Opioid Manag. 2016 Nov/Dec;12(6):405-419. doi: 10.5055/jom.2016.0360.
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\_Report\_Synopsis\_D3820C00004
Other Identifiers
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2011-001987-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D3820C00004
Identifier Type: -
Identifier Source: org_study_id
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