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
652
4 countries
117
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
117 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 4, 2011
CompletedFirst Posted
Study publicly available on registry
March 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
June 1, 2015
CompletedJune 1, 2015
May 1, 2015
1.4 years
March 4, 2011
October 13, 2014
May 29, 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.
- 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.
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 (117)
Research Site
Birmingham, Alabama, United States
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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
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Potsdam, BR, Germany
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Hamburg, 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
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Banská Bystrica, Slovakia
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Bratislava, Slovakia
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Košice, Slovakia
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Prešov, Slovakia
Related Publications (4)
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.
PMID: 28059433DERIVEDLawson 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 Pharmaceuticals, Wilm DE
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 4, 2011
First Posted
March 7, 2011
Study Start
March 1, 2011
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
June 1, 2015
Results First Posted
June 1, 2015
Record last verified: 2015-05