Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Opioid Tolerant Pediatric Subjects
Primary Purpose
Chronic Pain
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
oxymorphone IR
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring sickle cell anemia, juvenile rheumatoid arthritis, burn victim, cancer, Chronic pain of malignant or non-malignant etiology
Eligibility Criteria
Inclusion Criteria:
- Males or females 2 to ≤6 years of age, inclusive
- 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 >1 mg/kg qd oral morphine equivalent)
- Expected to continue to require a strong opioid for pain relief for at least 4 months
- Able to swallow the oxymorphone HCl immediate-release oral liquid
- Have been informed of the nature of the study and informed consent and assent by minor (if IRB required) has been obtained from the legally responsible parent/legal guardian in accordance with IRB requirements
Exclusion Criteria:
- Known allergy to, or a significant reaction to, oxymorphone or another opioid
- Life expectancy <4 months
- Any clinical condition in the investigator's opinion that would preclude participation
- Plan to undergo a surgical procedure within 1 month of study entry or anytime during study
- Currently prescribed a long-acting opioid (eg., Kadian® morphine sulfate extended release) as part of their analgesic regimen
- Received any investigational medication within 30 days prior to the first dose of study medication, or are scheduled to receive an investigational drug other than oxymorphone during the course of the study
- An ileostomy
- Received a monoamine oxidase inhibitor (MAOI) within 14 days prior to the start of study medication
- Investigator anticipates that the subject would be unable to comply with the protocol
- Parent/legal guardian is unable to complete the subject's daily study medication diary
- Parent/legal guardian is unable to effectively communicate the subject's status to the investigator
Sites / Locations
Outcomes
Primary Outcome Measures
Change in pain intensity from baseline to last assessment using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale.
Change in pain intensity from baseline to last assessment using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale.
Secondary Outcome Measures
Safety Assessment of Adverse Events, vital signs including oxygen saturation, Blood Pressure, and Heart Rate.
Safety Assessment of Adverse Events, vital signs including oxygen saturation, Blood Pressure, and Heart Rate.
Full Information
NCT ID
NCT01206907
First Posted
September 17, 2010
Last Updated
August 15, 2012
Sponsor
Endo Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01206907
Brief Title
Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Opioid Tolerant Pediatric Subjects
Official Title
AN OPEN-LABEL, NON-RANDOMIZED, MULTICENTER EFFECTIVENESS, SAFETY AND TOLERABILITY STUDY OF OXYMORPHONE HCl IMMEDIATE-RELEASE ORAL LIQUID IN OPIOID-TOLERANT PEDIATRIC SUBJECTS WITH CHRONIC PAIN REQUIRING AN AROUND THE CLOCK OPIOID
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Withdrawn
Why Stopped
The study is no longer required for the PREA for this product.
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Endo Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effectiveness, tolerability, and safety of oxymorphone immediate release (IR) oral liquid as an analgesic in pediatric subjects having severe to moderate chronic pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
sickle cell anemia, juvenile rheumatoid arthritis, burn victim, cancer, Chronic pain of malignant or non-malignant etiology
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
oxymorphone IR
Intervention Description
oxymorphone IR liquid
Primary Outcome Measure Information:
Title
Change in pain intensity from baseline to last assessment using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale.
Time Frame
weekly for 1 month during titration
Title
Change in pain intensity from baseline to last assessment using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale.
Time Frame
bi-weekly for three months in the maintenance phase
Secondary Outcome Measure Information:
Title
Safety Assessment of Adverse Events, vital signs including oxygen saturation, Blood Pressure, and Heart Rate.
Time Frame
weekly for 1 month during titration
Title
Safety Assessment of Adverse Events, vital signs including oxygen saturation, Blood Pressure, and Heart Rate.
Time Frame
bi-weekly for 3 months in the maintenance phase
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males or females 2 to ≤6 years of age, inclusive
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 >1 mg/kg qd oral morphine equivalent)
Expected to continue to require a strong opioid for pain relief for at least 4 months
Able to swallow the oxymorphone HCl immediate-release oral liquid
Have been informed of the nature of the study and informed consent and assent by minor (if IRB required) has been obtained from the legally responsible parent/legal guardian in accordance with IRB requirements
Exclusion Criteria:
Known allergy to, or a significant reaction to, oxymorphone or another opioid
Life expectancy <4 months
Any clinical condition in the investigator's opinion that would preclude participation
Plan to undergo a surgical procedure within 1 month of study entry or anytime during study
Currently prescribed a long-acting opioid (eg., Kadian® morphine sulfate extended release) as part of their analgesic regimen
Received any investigational medication within 30 days prior to the first dose of study medication, or are scheduled to receive an investigational drug other than oxymorphone during the course of the study
An ileostomy
Received a monoamine oxidase inhibitor (MAOI) within 14 days prior to the start of study medication
Investigator anticipates that the subject would be unable to comply with the protocol
Parent/legal guardian is unable to complete the subject's daily study medication diary
Parent/legal guardian is unable to effectively communicate the subject's status to the investigator
12. IPD Sharing Statement
Learn more about this trial
Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Opioid Tolerant Pediatric Subjects
We'll reach out to this number within 24 hrs