Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
An Open-Label 52-week Study to Assess the Long-Term Safety of NKTR-118 in Opioid-Induced Constipation (OIC) in Patients With Non-Cancer-Related Pain
1 other identifier
interventional
844
1 country
169
Brief Summary
The purpose of this study is to evaluate the long-term safety and tolerability of NKTR-118 treatment of opioid-induced constipation (OIC) in patients with non-cancer-related pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2011
169 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 14, 2011
CompletedFirst Posted
Study publicly available on registry
April 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
October 20, 2014
CompletedOctober 20, 2014
October 1, 2014
1.7 years
April 14, 2011
October 13, 2014
October 13, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Incidence of Patients Experiencing at Least One Adverse Event (AE)
The incidence of patients experiencing at least one AE during the randomized treatment and follow-up periods was calculated.
Baseline (Week 0) to end of the follow-up period
Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)
The incidence of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.
Baseline (Week 0) to end of the follow-up period
Incidence of Patients Experiencing Severe Adverse Events (SAEs)
The incidence of patients experiencing SAEs during the randomized treatment and follow-up periods was calculated.
Baseline (Week 0) to end of the follow-up period
Study Arms (2)
1
EXPERIMENTALOral Treatment
2
ACTIVE COMPARATOROral treatment
Interventions
Eligibility Criteria
You may qualify if:
- Provision of written informed consent prior to any study-specific procedures.
- 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.
You may not qualify if:
- Patients receiving Opioid regimen for treatment of pain related to cancer.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (169)
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
Related Publications (1)
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.
PMID: 25112584DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Mark Sostek
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2011
First Posted
April 15, 2011
Study Start
April 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
October 20, 2014
Results First Posted
October 20, 2014
Record last verified: 2014-10