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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01309841
Registration number
NCT01309841
Ethics application status
Date submitted
4/03/2011
Date registered
7/03/2011
Date last updated
1/06/2015
Titles & IDs
Public title
Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
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Scientific title
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)
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Secondary ID [1]
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2011-001987-24
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Secondary ID [2]
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D3820C00004
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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: 1 - Oral treatment
Experimental: 2 - Oral treatment
Placebo Comparator: 3 - Oral treatment
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 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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Response (Responder/Non-responder) to Study Drug During Weeks 1 to 12
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline (Week 1) to end of treatment (Week 12)
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Secondary outcome [1]
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Response (Responder/Non-responder) to Study Drug in the LIR Subgroup During Weeks 1 to 12
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Assessment method [1]
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Responder is defined as having at least 3 SBMs/week, with at least 1 SBM/week increase over baseline for at least 9 out of 12 weeks and at least 3 out of the last 4 weeks.
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Timepoint [1]
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Baseline (Week 1) to end of treatment (Week 12)
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Secondary outcome [2]
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Time (in Hours) to First Post-dose Laxation Without the Use of Rescue Laxatives Within the Previous 24 Hours
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Assessment method [2]
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Timepoint [2]
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12 weeks
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Secondary outcome [3]
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Change From Baseline in Mean Number of Days Per Week With at Least 1 SBM During Weeks 1 to 12
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Assessment method [3]
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Timepoint [3]
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12 weeks
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Secondary outcome [4]
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Change From Baseline in Degree of Straining
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Assessment method [4]
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A single-item straining question was asked via the eDiary: "How much did you strain during your bowel movement?" Patients responded on a 5 point Likert scale: 1=Not at all; 2=A little bit; 3=A moderate amount; 4=A great deal; 5=An extreme amount. A negative change from baseline indicates improvement.
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Timepoint [4]
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Baseline (Week 1) to end of treatment (Week 12)
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Secondary outcome [5]
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Change From Baseline in Stool Consistency (Bristol Stool Scale)
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Assessment method [5]
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Patients rated stool consistency through completion of the BSS after each BM. The 7 stool types are: 1. Separate hard lumps, like nuts (hard to pass); 2. Sausage-shaped, but lumpy; 3. Like sausage, but with cracks on its surface; 4. Like a sausage or snake, smooth and soft; 5. Soft blobs with clear cut edges (passed easily); 6. Fluffy pieces with ragged edges, a mushy stool; 7. Watery, no solid pieces. A positive change from baseline indicates improvement.
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Timepoint [5]
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Baseline (Week 1) to end of treatment (Week 12)
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Secondary outcome [6]
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Change From Baseline in Percent Numbers of Days With a CSBM (Complete Spontaneous Bowel Movement)
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Assessment method [6]
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A single-item question on the completeness of evacuation, developed and validated through 1:1 interviews with OIC patients, was asked via the eDiary: "Did you feel like your bowels were completely empty after the bowel movement?" Patients provided a yes or a no response. A positive change from baseline indicates improvement.
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Timepoint [6]
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Baseline (Week 1) to end of treatment (Week 12)
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Secondary outcome [7]
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Change From Baseline in Mean Spontaneous Bowel Movements/Week
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Assessment method [7]
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The number of spontaneous bowel movements/week was determined from the patient's eDiary.
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Timepoint [7]
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Baseline (Week 1) to end of treatment (Week 12)
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Secondary outcome [8]
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Time (in Hours) to First Post-dose Laxation Without the Use of Rescue Laxatives Within the Previous 24 Hours in the Laxative Inadequate Response (LIR) Subgroup
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Assessment method [8]
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Time to first post-dose laxation without the use of rescue laxatives within the last 24 hours was calculated in hours as: Date/Time of first post-dose laxation without rescue - First dose date/time.
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Timepoint [8]
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Baseline (Week 1) to end of treatment (Week 12)
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Secondary outcome [9]
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Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM)
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Assessment method [9]
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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 [9]
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Baseline (Week 1) to end of treatment (Week 12)
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Secondary outcome [10]
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Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL) Satisfaction Domain
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Assessment method [10]
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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 [10]
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Baseline (Week 1) to end of treatment (Week 12)
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Eligibility
Key inclusion criteria
- 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.
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Minimum age
18
Years
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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 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.
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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 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
1/03/2011
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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
1/08/2012
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Sample size
Target
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Accrual to date
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Final
652
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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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Recruitment hospital [2]
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Research Site - Darlinghurst
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Recruitment hospital [3]
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Research Site - Port Kembla
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Recruitment hospital [4]
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Research Site - Westmead
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Recruitment hospital [5]
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Research Site - Greenslopes
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Recruitment hospital [6]
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Research Site - Adelaide
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Recruitment hospital [7]
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Research Site - Fremantle
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Recruitment hospital [8]
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Research Site - Nedlands
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Recruitment postcode(s) [1]
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- Broadmeadow
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Recruitment postcode(s) [2]
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- Darlinghurst
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Recruitment postcode(s) [3]
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- Port Kembla
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Recruitment postcode(s) [4]
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- Westmead
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Recruitment postcode(s) [5]
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- Greenslopes
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Recruitment postcode(s) [6]
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- Adelaide
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Recruitment postcode(s) [7]
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- Fremantle
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Recruitment postcode(s) [8]
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- Nedlands
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Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Arkansas
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California
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Colorado
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Banska Bystrica
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Slovakia
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Bratislava
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Kosice
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Presov
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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, including those
patients that have inadequate response to laxative therapy (LIR).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01309841
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Trial related presentations / publications
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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 Pharmaceuticals, Wilm DE
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01309841
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