Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
NCT ID: NCT01336205
Last Updated: 2014-10-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
844 participants
INTERVENTIONAL
2011-04-30
2012-12-31
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
NONE
Study Groups
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1
Oral Treatment
NKTR-118
25 mg oral tablet once daily
2
Oral treatment
Usual care
As prescribed by the investigator
Interventions
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NKTR-118
25 mg oral tablet once daily
Usual care
As prescribed by the investigator
Eligibility Criteria
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Inclusion Criteria
* NEW PATIENTS ONLY: 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 the BMs over the previous 4 weeks); and Documented confirmed OIC (\<3 SBMs/week on average over the 2-week OIC confirmation period.
* PATIENTS ENROLLING FROM OTHER NKTR-118 STUDIES: Receiving a stable maintenance opioid regimen consisting of a total daily dose of 30 mg to 1000 mg or oral morphine, or equianalgesic amount(s) of 1 or more opioid therapies.
* FOR PATIENTS RANDOMIZED TO RECEIVE NKTR-118: Willingness to stop all laxatives and other bowel regimens including prune juice and herbal products throughout the 52-week treatment period, and to use only bisacodyl as rescue medication if 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 related 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
Athens, Alabama, United States
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Pell City, Alabama, United States
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Garden Grove, Arizona, United States
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Goodyear, 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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Tuscon, 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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Arcadia, California, United States
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Chino, California, United States
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Encino, California, United States
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Fremont, California, United States
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Garden Grove, California, United States
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Huntington Park, California, United States
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La Mesa, California, United States
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Laguna Hills, California, United States
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Lakewood, California, United States
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Long Beach, California, United States
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Oceanside, California, United States
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Orange, California, United States
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Pasadena, California, United States
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Riverside, California, United States
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San Bernardino, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Santa Ana, California, United States
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Walnut Creek, California, United States
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Whittier, California, United States
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Colorado Springs, Colorado, United States
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Stamford, Connecticut, United States
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Boynton Beach, Florida, United States
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Bradenton, Florida, United States
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Brooksville, Florida, United States
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Chiefland, Florida, United States
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Clearwater, Florida, United States
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Crystal River, Florida, United States
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Daytona Beach, Florida, United States
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DeBary, Florida, United States
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Deerfield Beach, Florida, United States
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Delray Beach, Florida, United States
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Edgewater, Florida, United States
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Eustis, Florida, United States
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Fort Myers, 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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Largo, Florida, United States
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Lauderhill, Florida, United States
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Miami, Florida, United States
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Naples, Florida, United States
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North Miami, Florida, United States
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Ocala, Florida, United States
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Orange City, Florida, United States
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Orlando, Florida, United States
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Oviedo, Florida, United States
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Pembroke Pines, Florida, United States
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Pinellas Park, Florida, United States
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Plantation, Florida, United States
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Port Orange, Florida, United States
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Port Saint Lucie, Florida, United States
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Saint Doral, Florida, United States
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South Miami, Florida, United States
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St. Petersburg, Florida, United States
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Tamarac, 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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West Palm, Florida, United States
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Winter Park, Florida, United States
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Alpharetta, Georgia, United States
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Atlanta, Georgia, United States
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Columbus, Georgia, United States
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Marietta, Georgia, United States
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Suwanee, Georgia, United States
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Tucker, Georgia, United States
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Boise, Idaho, United States
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Bloomington, Illinois, United States
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Chicago, Illinois, United States
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Peoria, Illinois, United States
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Schaumburg, Illinois, United States
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Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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Council Bluffs, Iowa, United States
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Kansas City, Kansas, United States
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Lansing, Kansas, United States
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Overland Park, Kansas, United States
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Wichita, Kansas, United States
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Louisville, Kentucky, United States
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Columbia, Maryland, United States
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Hollywood, Maryland, United States
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Pikesville, Maryland, United States
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Reisterstown, Maryland, United States
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Watertown, Massachusetts, United States
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Calamazoo, Michigan, United States
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Traverse City, Michigan, United States
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St Louis, Missouri, United States
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Bellevue, Nebraska, United States
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Fremont, Nebraska, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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Henderson, Nevada, United States
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Las Vegas, Nevada, United States
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Clifton, New Jersey, United States
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Freehold, New Jersey, United States
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Lumberton, New Jersey, 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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Willingboro, New Jersey, United States
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Albuquerque, New Mexico, 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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New York, New York, United States
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North Massapequa, New York, United States
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Charlotte, North Carolina, United States
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Elkin, North Carolina, United States
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Flat Rock, North Carolina, United States
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Harrisburg, North Carolina, United States
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Mooresville, North Carolina, United States
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Morganton, 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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Akron, Ohio, United States
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Beavercreek, Ohio, United States
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Centerville, Ohio, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Downingtown, Pennsylvania, United States
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Jenkintown, Pennsylvania, United States
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Norristown, 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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Charleston, South Carolina, United States
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Greer, 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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Clarksville, Tennessee, United States
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Jackson, Tennessee, United States
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Memphis, Tennessee, United States
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Milan, Tennessee, United States
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New Tazewell, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Hurst, Texas, United States
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Lexington, 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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Victoria, Texas, United States
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Clinton, Utah, United States
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Ogden, Utah, United States
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Salt Lake City, 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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Richmond, Virginia, United States
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Springfield, Virginia, United States
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Virginia Beach, Virginia, United States
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Middleton, Wisconsin, United States
Countries
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References
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Webster L, Chey WD, Tack J, Lappalainen J, Diva U, Sostek M. Randomised clinical trial: the long-term safety and tolerability of naloxegol in patients with pain and opioid-induced constipation. Aliment Pharmacol Ther. 2014 Oct;40(7):771-9. doi: 10.1111/apt.12899. Epub 2014 Aug 12.
Related Links
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Clinical\_Study\_Report\_Synopsis\_D3820C00008
Other Identifiers
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D3820C00008
Identifier Type: -
Identifier Source: org_study_id
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