Back to resultsAssessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related Pain
Primary Purpose
Opioid-Induced Constipation
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
NKTR-118
NKTR-118
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-Induced Constipation focused on measuring Cancer-Related Pain, Opioid-Induced Constipation, OIC
Eligibility Criteria
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.
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.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
1 (part A and B)
2 (part A and B)
3 (part A only)
Arm Description
Oral treatment
Oral treatment
Oral treatment
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01384292
Brief Title
Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related Pain
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Why Stopped
The study was stopped early due to recruitment challenges
Study Start Date
June 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Induced Constipation
Keywords
Cancer-Related Pain, Opioid-Induced Constipation, OIC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 (part A and B)
Arm Type
Experimental
Arm Description
Oral treatment
Arm Title
2 (part A and B)
Arm Type
Experimental
Arm Description
Oral treatment
Arm Title
3 (part A only)
Arm Type
Placebo Comparator
Arm Description
Oral treatment
Intervention Type
Drug
Intervention Name(s)
NKTR-118
Intervention Description
12.5 mg oral tablet once daily
Intervention Type
Drug
Intervention Name(s)
NKTR-118
Intervention Description
25 mg oral tablet once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral treatment
Primary Outcome Measure Information:
Title
Response (Responder/Non-responder) to Study Drug
Description
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.
Time Frame
Baseline to Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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.
Facility Information:
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Huntsville
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Alabama
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United States
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Casa Grande
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Arizona
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United States
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Phoenix
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Arizona
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United States
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Tucson
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Arizona
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United States
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Fort Smith
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Arkansas
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United States
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Hot Springs
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Arkansas
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United States
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North Little Rock
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Arkansas
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United States
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Encino
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United States
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Fountain Valley
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Gilroy
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Laguna Hills
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United States
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Montebello
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California
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United States
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Orange
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United States
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Riverside
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California
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United States
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San Bernandino
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California
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Aurora
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Colorado
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Denver
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Colorado
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Baypines
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Boynton Beach
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Florida
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United States
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Celebration
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United States
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Clearwater
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Coral Gables
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Hialeah
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Plantation
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Danville
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Bellaire
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Corpus Christi
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Dallas
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Houston
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Lubbock
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San Antonio
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Sugarland
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Fairfax
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Broadmeadow
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Australia
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Frankston
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Australia
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Malvern
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Australia
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Parkville
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Victoria
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Australia
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Fremantle
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Australia
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Brussels
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Belgium
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Edegem
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Belgium
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Mons
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Belgium
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Wetteren
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Belgium
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Haskovo
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Bulgaria
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Pleven
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Bulgaria
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Ruse
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Bulgaria
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Shumen
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Bulgaria
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Sofia
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Bulgaria
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Varna
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Bulgaria
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Zagreb
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Croatia
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Benesov
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Czech Republic
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Ceske Budejovice
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Czech Republic
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Praha 2
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Czech Republic
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Berlin
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BE
Country
Germany
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Wiesbaden
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HE
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Germany
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Hamburg
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HH
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Germany
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Offenbach
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Germany
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Brzozow
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Poland
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Bydgoszcz
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Poland
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Gdansk
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Poland
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Gliwice
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Poland
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Poznan
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Poland
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Warsaw
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Poland
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Wroclaw
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Poland
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Ponce
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Puerto Rico
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Craiova
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Dolj
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Romania
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Ploiesti
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Prahova
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Romania
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Baia Mare
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Romania
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Braila
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Romania
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Brasov
Country
Romania
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Bucuresti
Country
Romania
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Cluj-napoca
Country
Romania
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Onesti
Country
Romania
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Bardejov
Country
Slovakia
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Bratislava
Country
Slovakia
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Kosice
Country
Slovakia
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Presov
Country
Slovakia
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Port Elizabeth
State/Province
Eastern Cape
Country
South Africa
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Bloemfontein
State/Province
Free State
Country
South Africa
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Benoni
State/Province
Gauteng
Country
South Africa
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Pretoria
State/Province
Gauteng
Country
South Africa
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Vereeniging
State/Province
Gauteng
Country
South Africa
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Durban
State/Province
Kz-natal
Country
South Africa
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Goodwood
State/Province
W Cape
Country
South Africa
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Sevilla
State/Province
Andalucia
Country
Spain
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Valencia
State/Province
Comunidad Valenciana
Country
Spain
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A Coruna
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Galicia
Country
Spain
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Penarth
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CRF
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United Kingdom
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Norwich
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Norfolk
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United Kingdom
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Guildford
State/Province
Surrey
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United Kingdom
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Chippenham
State/Province
Wilts
Country
United Kingdom
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Coventry
Country
United Kingdom
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City
London
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1388&filename=Clinical_Study_Report_Synopsis_D3820C00006.pdf
Description
Clinical_Study_Report_Synopsis_D3820C00006
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Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related Pain
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