Back to resultsAssessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
Primary Purpose
Opioid-Induced Constipation (OIC)
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
NKTR-118
Usual care
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.
- NEW PATIENTS ONLY: 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 the BMs over the previous 4 weeks); and Documented confirmed OIC (<3 SBMs/week on average over the 2-week OIC confirmation period.
- PATIENTS ENROLLING FROM OTHER NKTR-118 STUDIES: Receiving a stable maintenance opioid regimen consisting of a total daily dose of 30 mg to 1000 mg or oral morphine, or equianalgesic amount(s) of 1 or more opioid therapies.
- FOR PATIENTS RANDOMIZED TO RECEIVE NKTR-118: Willingness to stop all laxatives and other bowel regimens including prune juice and herbal products throughout the 52-week treatment period, and to use only bisacodyl as rescue medication if 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 related 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 Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Oral Treatment
Oral treatment
Outcomes
Primary Outcome Measures
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.
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.
Incidence of Patients Experiencing Severe Adverse Events (SAEs)
The incidence of patients experiencing SAEs during the randomized treatment and follow-up periods was calculated.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01336205
Brief Title
Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
Official Title
An Open-Label 52-week Study to Assess the Long-Term Safety of NKTR-118 in Opioid-Induced Constipation (OIC) in Patients With Non-Cancer-Related Pain
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 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 long-term safety and tolerability of NKTR-118 treatment of opioid-induced constipation (OIC) in patients with non-cancer-related pain.
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
None (Open Label)
Allocation
Randomized
Enrollment
844 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Oral Treatment
Arm Title
2
Arm Type
Active Comparator
Arm Description
Oral treatment
Intervention Type
Drug
Intervention Name(s)
NKTR-118
Intervention Description
25 mg oral tablet once daily
Intervention Type
Drug
Intervention Name(s)
Usual care
Intervention Description
As prescribed by the investigator
Primary Outcome Measure Information:
Title
Incidence of Patients Experiencing at Least One Adverse Event (AE)
Description
The incidence of patients experiencing at least one AE during the randomized treatment and follow-up periods was calculated.
Time Frame
Baseline (Week 0) to end of the follow-up period
Title
Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)
Description
The incidence of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.
Time Frame
Baseline (Week 0) to end of the follow-up period
Title
Incidence of Patients Experiencing Severe Adverse Events (SAEs)
Description
The incidence of patients experiencing SAEs during the randomized treatment and follow-up periods was calculated.
Time Frame
Baseline (Week 0) to end of the follow-up period
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.
NEW PATIENTS ONLY: 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 the BMs over the previous 4 weeks); and Documented confirmed OIC (<3 SBMs/week on average over the 2-week OIC confirmation period.
PATIENTS ENROLLING FROM OTHER NKTR-118 STUDIES: Receiving a stable maintenance opioid regimen consisting of a total daily dose of 30 mg to 1000 mg or oral morphine, or equianalgesic amount(s) of 1 or more opioid therapies.
FOR PATIENTS RANDOMIZED TO RECEIVE NKTR-118: Willingness to stop all laxatives and other bowel regimens including prune juice and herbal products throughout the 52-week treatment period, and to use only bisacodyl as rescue medication if 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 related 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
Official's Role
Study Director
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Athens
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Country
United States
Facility Name
Research Site
City
Saint George
State/Province
Utah
Country
United States
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Research Site
City
West Jordan
State/Province
Utah
Country
United States
Facility Name
Research Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Springfield
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Virginia Beach
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Middleton
State/Province
Wisconsin
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25112584
Citation
Webster L, Chey WD, Tack J, Lappalainen J, Diva U, Sostek M. Randomised clinical trial: the long-term safety and tolerability of naloxegol in patients with pain and opioid-induced constipation. Aliment Pharmacol Ther. 2014 Oct;40(7):771-9. doi: 10.1111/apt.12899. Epub 2014 Aug 12.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1390&filename=Clinical_Study_Report_Synopsis_D3820C00008.pdf
Description
Clinical_Study_Report_Synopsis_D3820C00008
Learn more about this trial
Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
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