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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
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)
Secondary ID [1] 0 0
D3820C00007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Opioid-Induced Constipation (OIC) 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Mental Health 0 0 0 0
Addiction

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline (Week 0) to end of the follow-up period (Week 14)
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline (Week 0) to end of the follow-up period (Week 14)
Primary outcome [3] 0 0
Incidence of Patients Experiencing Severe Adverse Events (SAEs) - The incidence of patients experiencing SAEs during the randomized treatment and follow-up periods was calculated.
Timepoint [3] 0 0
Baseline (Week 0) to end of the follow-up period (Week 14)
Secondary outcome [1] 0 0
Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM) - 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.
Timepoint [1] 0 0
Baseline (prior to treatment) to last on-treatment assessment (up to Week 12)
Secondary outcome [2] 0 0
Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL) - 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.
Timepoint [2] 0 0
Baseline (prior to treatment) to last on-treatment assessment (up to Week 12)

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.
Minimum age
18 Years
Maximum age
84 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
Research Site - Broadmeadow
Recruitment hospital [2] 0 0
Research Site - Darlinghurst
Recruitment hospital [3] 0 0
Research Site - Port Kembla
Recruitment hospital [4] 0 0
Research Site - Westmead
Recruitment hospital [5] 0 0
Research Site - Greenslopes
Recruitment hospital [6] 0 0
Research Site - Adelaide
Recruitment hospital [7] 0 0
Research Site - Fremantle
Recruitment hospital [8] 0 0
Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
- Broadmeadow
Recruitment postcode(s) [2] 0 0
- Darlinghurst
Recruitment postcode(s) [3] 0 0
- Port Kembla
Recruitment postcode(s) [4] 0 0
- Westmead
Recruitment postcode(s) [5] 0 0
- Greenslopes
Recruitment postcode(s) [6] 0 0
- Adelaide
Recruitment postcode(s) [7] 0 0
- Fremantle
Recruitment postcode(s) [8] 0 0
- Nedlands
Recruitment outside Australia
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Alabama
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Massachusetts
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New York
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Banska Bystrica
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01395524
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.
Public notes

Contacts
Principal investigator
Name 0 0
Mark Sostek
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications