Back to resultsAssessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
Primary Purpose
Opioid-Induced Constipation (OIC)
Status
Completed
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 (OIC) focused on measuring Non-Cancer-Related Pain, Opioid-Induced Constipation
Eligibility Criteria
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.
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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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
1
2
3
Arm Description
Oral treatment
Oral treatment
Oral treatment
Outcomes
Primary Outcome Measures
Response (Responder/Non-responder) to Study Drug During Weeks 1 to 12
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.
Secondary Outcome Measures
Response (Responder/Non-responder) to Study Drug in the LIR Subgroup During Weeks 1 to 12
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.
Time (in Hours) to First Post-dose Laxation Without the Use of Rescue Laxatives Within the Previous 24 Hours
Change From Baseline in Mean Number of Days Per Week With at Least 1 SBM During Weeks 1 to 12
Change From Baseline in Degree of Straining
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.
Change From Baseline in Stool Consistency (Bristol Stool Scale)
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.
Change From Baseline in Percent Numbers of Days With a CSBM (Complete Spontaneous Bowel Movement)
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.
Change From Baseline in Mean Spontaneous Bowel Movements/Week
The number of spontaneous bowel movements/week was determined from the patient's eDiary.
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
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.
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.
Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL) Satisfaction Domain
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01309841
Brief Title
Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
Official 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)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Induced Constipation (OIC)
Keywords
Non-Cancer-Related Pain, Opioid-Induced Constipation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
652 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Oral treatment
Arm Title
2
Arm Type
Experimental
Arm Description
Oral treatment
Arm Title
3
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 tablet once daily
Primary Outcome Measure Information:
Title
Response (Responder/Non-responder) to Study Drug During Weeks 1 to 12
Description
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.
Time Frame
Baseline (Week 1) to end of treatment (Week 12)
Secondary Outcome Measure Information:
Title
Response (Responder/Non-responder) to Study Drug in the LIR Subgroup During Weeks 1 to 12
Description
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.
Time Frame
Baseline (Week 1) to end of treatment (Week 12)
Title
Time (in Hours) to First Post-dose Laxation Without the Use of Rescue Laxatives Within the Previous 24 Hours
Time Frame
12 weeks
Title
Change From Baseline in Mean Number of Days Per Week With at Least 1 SBM During Weeks 1 to 12
Time Frame
12 weeks
Title
Change From Baseline in Degree of Straining
Description
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.
Time Frame
Baseline (Week 1) to end of treatment (Week 12)
Title
Change From Baseline in Stool Consistency (Bristol Stool Scale)
Description
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.
Time Frame
Baseline (Week 1) to end of treatment (Week 12)
Title
Change From Baseline in Percent Numbers of Days With a CSBM (Complete Spontaneous Bowel Movement)
Description
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.
Time Frame
Baseline (Week 1) to end of treatment (Week 12)
Title
Change From Baseline in Mean Spontaneous Bowel Movements/Week
Description
The number of spontaneous bowel movements/week was determined from the patient's eDiary.
Time Frame
Baseline (Week 1) to end of treatment (Week 12)
Title
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
Description
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.
Time Frame
Baseline (Week 1) to end of treatment (Week 12)
Title
Change From Baseline in Patient Assessment of Constipation Symptoms Questionnaire (PAC-SYM)
Description
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.
Time Frame
Baseline (Week 1) to end of treatment (Week 12)
Title
Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL) Satisfaction Domain
Description
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.
Time Frame
Baseline (Week 1) to end of treatment (Week 12)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Sostek
Organizational Affiliation
AstraZeneca Pharmaceuticals, Wilm DE
Official's Role
Study Director
Facility Information:
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Birmingham
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Calera
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Glendale
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Paramount
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Sacramento
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San Diego
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Denver
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Hialeah
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Orlando
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Austin
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Dallas
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Houston
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Australia
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Darlinghurst
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Australia
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Port Kembla
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Australia
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Westmead
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Australia
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Australia
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Australia
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Nedlands
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Australia
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Berlin
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Germany
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Germany
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Dietzenbach
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Germany
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Germany
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Germany
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Schwerin
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Country
Germany
Facility Name
Research Site
City
Celle
State/Province
NI
Country
Germany
Facility Name
Research Site
City
Hannover
State/Province
NI
Country
Germany
Facility Name
Research Site
City
Essen
State/Province
NW
Country
Germany
Facility Name
Research Site
City
Mainz
State/Province
RP
Country
Germany
Facility Name
Research Site
City
Kiel
State/Province
SH
Country
Germany
Facility Name
Research Site
City
Dresden
State/Province
SN
Country
Germany
Facility Name
Research Site
City
Leipzig
State/Province
SN
Country
Germany
Facility Name
Research Site
City
Banska Bystrica
Country
Slovakia
Facility Name
Research Site
City
Bratislava
Country
Slovakia
Facility Name
Research Site
City
Kosice
Country
Slovakia
Facility Name
Research Site
City
Presov
Country
Slovakia
12. IPD Sharing Statement
Citations:
PubMed Identifier
28059433
Citation
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.
Results Reference
derived
PubMed Identifier
27342744
Citation
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.
Results Reference
derived
PubMed Identifier
26535126
Citation
Tack J, Lappalainen J, Diva U, Tummala R, Sostek M. Efficacy and safety of naloxegol in patients with opioid-induced constipation and laxative-inadequate response. United European Gastroenterol J. 2015 Oct;3(5):471-80. doi: 10.1177/2050640615604543.
Results Reference
derived
PubMed Identifier
24896818
Citation
Chey WD, Webster L, Sostek M, Lappalainen J, Barker PN, Tack J. Naloxegol for opioid-induced constipation in patients with noncancer pain. N Engl J Med. 2014 Jun 19;370(25):2387-96. doi: 10.1056/NEJMoa1310246. Epub 2014 Jun 4.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1853&filename=Clinical_Study_Report_Synopsis_D3820C00004.pdf
Description
Clinical_Study_Report_Synopsis_D3820C00004
Learn more about this trial
Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
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