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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01384292




Registration number
NCT01384292
Ethics application status
Date submitted
28/06/2011
Date registered
29/06/2011
Date last updated
1/06/2015

Titles & IDs
Public title
Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related Pain
Scientific title
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NKTR-118 in Relieving Opioid-Induced Constipation (OIC) in Patients With Cancer-Related Pain
Secondary ID [1] 0 0
2011-001985-16
Secondary ID [2] 0 0
D3820C00006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Opioid-Induced Constipation 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
Cancer 0 0 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - NKTR-118
Treatment: Drugs - NKTR-118
Treatment: Drugs - Placebo

Experimental: 1 (part A and B) - Oral treatment

Experimental: 2 (part A and B) - Oral treatment

Placebo Comparator: 3 (part A only) - 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 treatment

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

Outcomes
Primary outcome [1] 0 0
Response (Responder/Non-responder) to Study Drug - Response (responder/non-responder) to study drug, where a responder was defined as having at least 3 rescue-free bowel movements (RFBMs) per week during the 4-week Part A treatment period, with at least 1 RFBM per week increase over baseline for at least 3 out of 4 weeks. An RFBM was defined as a bowel movement (BM) without rescue laxatives in the previous 24 hours.
Timepoint [1] 0 0
Baseline to Week 4

Eligibility
Key inclusion criteria
- Provision of written informed consent prior to any study-specific procedures.

- Men and women aged 18 or older.

- Histologically or cytologically confirmed neoplasm causing pain and requiring
management with opioids.

- Self-reported active symptoms of OIC at screening (<3 RFBMs/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 RFBMs/week on average aver the 2-week OIC
confirmation period.

- Receiving a stable maintenance opioid regimen consisting of a total daily dose of >30
mg of oral morphine, or equianalgesic amount(s) of 1 or more opioid therapies for a
minimum of 4 weeks prior to screening for cancer-related pain with no anticipated
change in opioid dose requirement over the proposed study period as a result of
disease progression.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients receiving Opioid regimen for treatment of pain other than related to cancer.

- Any condition that may have affected the permeability of the blood-brain barrier, eg,
known brain metastases, meningeal metastases, brain injury, multiple sclerosis, recent
brain injury, uncontrolled epilepsy.

- Patients with cancer-related pain due to ovarian cancer, leukaemia, or lymphoma are
excluded. Patients with multiple myeloma will be allowed.

- Patients requiring radiation therapy between the diaphragm and pelvis 4 weeks prior to
Visit 1 (screening) and/or during Part A of the study are excluded. Any patients with
suspected clinically relevant radiation-induced injury of small or large intestine are
excluded.

- 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
Terminated
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,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Broadmeadow
Recruitment hospital [2] 0 0
Research Site - Frankston
Recruitment hospital [3] 0 0
Research Site - Malvern
Recruitment hospital [4] 0 0
Research Site - Parkville
Recruitment hospital [5] 0 0
Research Site - Fremantle
Recruitment postcode(s) [1] 0 0
- Broadmeadow
Recruitment postcode(s) [2] 0 0
- Frankston
Recruitment postcode(s) [3] 0 0
- Malvern
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- Parkville
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- Fremantle
Recruitment outside Australia
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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 compare the effect of NKTR-118 with placebo in the treatment
of opioid-induced constipation (OIC) in patients with cancer-related pain, including those
patients that have inadequate response to laxative therapy (LIR).

The study consists of 2 parts; A initial 4-week treatment period (part A) and then a 12 week
extension with active treatment (part B).
Trial website
https://clinicaltrials.gov/show/NCT01384292
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT01384292