A 12-week Extension of the Phase III Study (D3820C00004) to Assess the Effect and Safety of NKTR-118 in Patients With Non-cancer-related Pain and Opioid-induced Constipation
A Randomized, Double-Blind, Placebo-Controlled 12-Week Extension Study to Assess the Safety and Tolerability of NKTR-118 in Patients With Non-Cancer-Related Pain and Opioid-Induced Constipation (OIC)
1 other identifier
interventional
302
4 countries
116
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 over a 6-month period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2011
Shorter than P25 for phase_3
116 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
First Submitted
Initial submission to the registry
June 28, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedFirst Posted
Study publicly available on registry
July 15, 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 17, 2015
CompletedFebruary 23, 2017
January 1, 2017
1.2 years
June 28, 2011
October 13, 2014
January 9, 2017
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 (Week 14)
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 (Week 14)
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 (Week 14)
Secondary Outcomes (2)
Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM)
Baseline (prior to treatment) to last on-treatment assessment (up to Week 12)
Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL)
Baseline (prior to treatment) to last on-treatment assessment (up to Week 12)
Study Arms (3)
NKTR-118 12.5mg
EXPERIMENTALNKTR-118 25mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Must have completed the 12-week study D3820C00004 through Visit 8.
- Provision of written informed consent prior to any study-specific procedures.
- Men and women who were between the ages of \>18 and \<85 years at the time of the screening visit for study D3820C00004.
- Continuing to receive 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.
- Willingness to continue abstinence from all laxatives and other bowel regimens including prune juice and herbal products throughout this additional 12-week treatment period, and to use only bisacodyl as rescue medication if a bowel movement (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 the screening visit of study D3820C00004 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 risk to the patient.
- Pregnancy or lactation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (116)
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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Crystal River, 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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Jacksonville, 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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Avon, Indiana, United States
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Evansville, 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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Leipzig, Saxony, Germany
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Kiel, Schleswig-Holstein, Germany
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Berlin, Germany
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Dresden, 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 (2)
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: 28059433BACKGROUNDLawson 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: 27342744DERIVED
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
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2011
First Posted
July 15, 2011
Study Start
July 1, 2011
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
February 23, 2017
Results First Posted
June 17, 2015
Record last verified: 2017-01