Back to resultsOpen-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects
Primary Purpose
Chronic Pain
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Oxymorphone ER
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Opioid tolerant, Pediatric, Male 6-17 years of age, Female 6-17 years of age, Pain, Non malignant, Malignant
Eligibility Criteria
Inclusion Criteria:
- Have chronic cancer or non-cancer pain, currently requiring treatment of pain with a strong opioid for at least 5 days (3 of 5 days at a dose greater than or equal to 45 mg/daily (qd) oral morphine equivalent)
- Weigh at least 50 kg
- Expected to continue to require a strong opioid for pain relief for at least 4 weeks and up to 4 months.
Exclusion Criteria:
- Have a life expectancy <4 weeks
- Plan to undergo a surgical procedure within 3 days of study entry or during the Titration Period
- Have dysphagia or difficulty swallowing whole tablets
- Have a previous exposure to oxymorphone
- Have an ileostomy
Sites / Locations
- Arkansas Childrens's Hospital-Division of Pediatric Anestesia and Pain Medicine
- Stanford University School of Medicine
- The Children's Hospital
- Connecticut Children's Medical Center
- Children's National Medical Center
- Florida Institute of Medical Research
- Tukoi Clinical Research
- St. Joseph's Children's Hospital of Tampa
- Taylor Research, LLC
- Rehabilitation Associates of Indiana
- University of Louisville Reserach Foundation, Inc.
- The Center for Clinical Research
- Hershey Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oxymorphone ER
Arm Description
Outcomes
Primary Outcome Measures
Extent of Exposure to Oxymorphone Extended-Release: Average Daily Dose
Data based on drug accountability data from the case report forms. Data is based on the number of enrolled participants in each treatment period. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.
Secondary Outcome Measures
Extent of Exposure to Oxymorphone Extended-Release: Total Number of Tablets Taken
Data based on drug accountability data from the case report forms. Data is based on the number of enrolled participants in each treatment period. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.
Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Daily Dose
Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.
Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Average Number of Daily Rescues
Average number of daily rescues per day by participants. Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.
Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Number of Doses
Total number of doses (Tablets) taken by participants. Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.
Full Information
NCT ID
NCT00765856
First Posted
October 2, 2008
Last Updated
November 20, 2020
Sponsor
Endo Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00765856
Brief Title
Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects
Official Title
An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic Pain.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
Terminated new protocol developed which incorporated Pharmacokinetics
Study Start Date
November 17, 2008 (Actual)
Primary Completion Date
February 22, 2010 (Actual)
Study Completion Date
February 22, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Endo Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients will convert from current opioid to Oxymorphone ER and undergo titration. During the Titration Period, subjects will receive daily oxymorphone Extended Release tablets(s) every 12 hours. Dosing adjustments will be based on the review of the subject's pain scores. Oxymorphone IR 5 mg will be provided to be used as supplemental "breakthrough" pain medication (as needed). Titration Period will end when the fixed dose of study medication is tolerated and the subject achieves adequate analgesia. Subjects will then proceed to the open-label 3-month maintenance period on the fixed dose of study medication established during the Titration Period.
Detailed Description
An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic Pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Opioid tolerant, Pediatric, Male 6-17 years of age, Female 6-17 years of age, Pain, Non malignant, Malignant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxymorphone ER
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Oxymorphone ER
Other Intervention Name(s)
Opana ER, Opana
Intervention Description
Oxymorphone ER dosing adjustments made under the direction of the Investigator during the Titration Period.
Oxymorphone IR (Opana) IR 5mg tablet - used as rescue medications
Primary Outcome Measure Information:
Title
Extent of Exposure to Oxymorphone Extended-Release: Average Daily Dose
Description
Data based on drug accountability data from the case report forms. Data is based on the number of enrolled participants in each treatment period. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.
Time Frame
Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
Secondary Outcome Measure Information:
Title
Extent of Exposure to Oxymorphone Extended-Release: Total Number of Tablets Taken
Description
Data based on drug accountability data from the case report forms. Data is based on the number of enrolled participants in each treatment period. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.
Time Frame
Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
Title
Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Daily Dose
Description
Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.
Time Frame
Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
Title
Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Average Number of Daily Rescues
Description
Average number of daily rescues per day by participants. Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.
Time Frame
Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
Title
Extent of Exposure to Oxymorphone Immediate-Release Rescue Medication: Total Number of Doses
Description
Total number of doses (Tablets) taken by participants. Data based on drug accountability data from the case report forms. Data with missing dates are included in calculation. Data is based on the number of enrolled participants in each treatment period. Two (2) participants did not use Oxymorphone IR as rescue medication in the Titration period. Therefore, 25 out of 27 participants were analyzed for this outcome measure. All participants entering maintenance period finished titration period. Study was terminated early by Sponsor due to a change in the FDA postmarketing requirement. The study was not terminated for safety reasons.
Time Frame
Day 1 up to Day 112 (approximately 4 weeks for titration period and 12 weeks for the maintenance period)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have chronic cancer or non-cancer pain, currently requiring treatment of pain with a strong opioid for at least 5 days (3 of 5 days at a dose greater than or equal to 45 mg/daily (qd) oral morphine equivalent)
Weigh at least 50 kg
Expected to continue to require a strong opioid for pain relief for at least 4 weeks and up to 4 months.
Exclusion Criteria:
Have a life expectancy <4 weeks
Plan to undergo a surgical procedure within 3 days of study entry or during the Titration Period
Have dysphagia or difficulty swallowing whole tablets
Have a previous exposure to oxymorphone
Have an ileostomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sr. Director CR&D
Organizational Affiliation
Endo Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Arkansas Childrens's Hospital-Division of Pediatric Anestesia and Pain Medicine
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
The Children's Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Florida Institute of Medical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32257
Country
United States
Facility Name
Tukoi Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
34104
Country
United States
Facility Name
St. Joseph's Children's Hospital of Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33618
Country
United States
Facility Name
Taylor Research, LLC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Rehabilitation Associates of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
University of Louisville Reserach Foundation, Inc.
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
The Center for Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17112
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects
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