Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NKTR-118 in Patients With Non-Cancer-Related Pain and Opioid-Induced Constipation (OIC)
2 other identifiers
interventional
700
8 countries
120
Brief Summary
The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain, including those patients that have inadequate response to laxative therapy (LIR).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2011
120 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
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 24, 2011
CompletedFirst Posted
Study publicly available on registry
March 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedResults Posted
Study results publicly available
June 2, 2015
CompletedJune 2, 2015
May 1, 2015
1.5 years
March 24, 2011
October 13, 2014
June 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Response (Responder/Non-responder) to Study Drug During Weeks 1 to 12
Responder was defined as having at least 3 spontaneous bowel movements (SBMs)/week with at least 1 SBM/week increase over baseline for at least 9 out of the 12 treatment weeks and 3 out of the last 4 treatment weeks during the double-blind treatment period. An SBM is a bowel movement occurring 24 hours or more since the last use of rescue medication.
Baseline (Week 1) to end of treatment (Week 12)
Secondary Outcomes (10)
Response (Responder/Non-responder) to Study Drug in the LIR Subgroup During Weeks 1 to 12
Baseline (Week 1) to end of treatment (Week 12)
Time (in Hours) to First Post-dose Laxation Without the Use of Rescue Laxatives Within the Previous 24 Hours
12 weeks
Change From Baseline in Mean Number of Days Per Week With at Least 1 SBM During Weeks 1 to 12
12 weeks
Change From Baseline in Degree of Straining
Baseline (Week 1) to end of treatment (Week 12)
Change From Baseline in Stool Consistency (Bristol Stool Scale)
Baseline (Week 1) to end of treatment (Week 12)
- +5 more secondary outcomes
Study Arms (3)
1
EXPERIMENTALOral treatment
2
EXPERIMENTALOral treatment
3
PLACEBO COMPARATOROral treatment
Interventions
Eligibility Criteria
You may qualify if:
- Provision of written informed consent prior to any study-specific procedures.
- 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.
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 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 (120)
Research Site
Mobile, Alabama, United States
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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
Related Publications (3)
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.
PMID: 27342744DERIVEDTack 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.
PMID: 26535126DERIVEDChey 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.
PMID: 24896818DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Mark Sostek
- 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
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2011
First Posted
March 28, 2011
Study Start
March 1, 2011
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
June 2, 2015
Results First Posted
June 2, 2015
Record last verified: 2015-05