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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01395524
Registration number
NCT01395524
Ethics application status
Date submitted
28/06/2011
Date registered
15/07/2011
Date last updated
23/02/2017
Titles & IDs
Public title
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
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Scientific title
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)
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Secondary ID [1]
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D3820C00007
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Opioid-Induced Constipation (OIC)
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Mental Health
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Addiction
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - NKTR-118
Treatment: Drugs - NKTR-118
Treatment: Drugs - Placebo
Experimental: NKTR-118 12.5mg -
Experimental: NKTR-118 25mg -
Placebo comparator: Placebo -
Treatment: Drugs: NKTR-118
12.5 mg oral tablet once daily
Treatment: Drugs: NKTR-118
25 mg oral tablet once daily
Treatment: Drugs: Placebo
Oral tablet intake once daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of Patients Experiencing at Least One Adverse Event (AE)
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Assessment method [1]
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The incidence of patients experiencing at least one AE during the randomized treatment and follow-up periods was calculated.
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Timepoint [1]
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Baseline (Week 0) to end of the follow-up period (Week 14)
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Primary outcome [2]
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Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)
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Assessment method [2]
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The incidence of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.
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Timepoint [2]
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Baseline (Week 0) to end of the follow-up period (Week 14)
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Primary outcome [3]
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Incidence of Patients Experiencing Severe Adverse Events (SAEs)
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Assessment method [3]
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The incidence of patients experiencing SAEs during the randomized treatment and follow-up periods was calculated.
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Timepoint [3]
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Baseline (Week 0) to end of the follow-up period (Week 14)
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Secondary outcome [1]
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Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM)
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Assessment method [1]
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The PAC-SYM questionnaire is a 12-item questionnaire that evaluates the severity of symptoms of constipation in 3 domains (stool, rectal, and abdominal symptoms) on a 5-point Likert scale ranging from 0 (absent) to 4 (very severe) in the 2 weeks (14 days) prior to assessment. Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items (ie, symptoms). The range of the domain or total score is 0 (response is 'absent' for each item) to 4 (response is 'very severe' for each item). A negative change from baseline indicates improvement.
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Timepoint [1]
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Secondary outcome [2]
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Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL)
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Assessment method [2]
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The PAC-QOL scale is a 28-item self-report instrument designed to evaluate the burden of constipation on patients' everyday functioning and well-being in the 2 weeks (14 days) prior to assessment. Each item is rated on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely). The instrument can be used to generate an overall score, but is also reported to assess 4 specific constipation-related domains including: 1) Worries and concerns (11 items), 2) Physical discomfort (4 items), 3) Psychosocial discomfort (8 items), and 4) Satisfaction (5 items). Each domain score is the mean of the non-missing items for that domain. The total score is the mean of all non-missing items. The range of the domain or total score is 0 (response is 'not at all' for each item) to 4 (response is 'extremely' for each item). A negative change from baseline indicates improvement.
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Timepoint [2]
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Baseline (prior to treatment) to last on-treatment assessment (up to Week 12)
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Eligibility
Key inclusion criteria
* 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.
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Minimum age
18
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Maximum age
84
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2012
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Sample size
Target
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Accrual to date
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Final
302
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
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Recruitment hospital [1]
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Research Site - Broadmeadow
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Research Site - Darlinghurst
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- Broadmeadow
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- Darlinghurst
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- Port Kembla
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- Adelaide
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- Nedlands
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT01395524
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Trial related presentations / publications
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. 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.
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Public notes
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Contacts
Principal investigator
Name
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Mark Sostek
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Address
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AstraZeneca
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01395524
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