Chronic Pain
Conditions
Keywords
sickle cell anemia, juvenile rheumatoid arthritis, burn victim, cancer, Chronic pain of malignant or non-malignant etiology
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.
Interventions
DRUGoxymorphone IR
oxymorphone IR liquid
Sponsors
Endo Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
1. Males or females 2 to ≤6 years of age, inclusive 2. 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) 3. Expected to continue to require a strong opioid for pain relief for at least 4 months 4. Able to swallow the oxymorphone HCl immediate-release oral liquid 5. 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
1. Known allergy to, or a significant reaction to, oxymorphone or another opioid 2. Life expectancy \<4 months 3. Any clinical condition in the investigator's opinion that would preclude participation 4. Plan to undergo a surgical procedure within 1 month of study entry or anytime during study 5. Currently prescribed a long-acting opioid (eg., Kadian® morphine sulfate extended release) as part of their analgesic regimen 6. 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 7. An ileostomy 8. Received a monoamine oxidase inhibitor (MAOI) within 14 days prior to the start of study medication 9. Investigator anticipates that the subject would be unable to comply with the protocol 10. Parent/legal guardian is unable to complete the subject's daily study medication diary 11. Parent/legal guardian is unable to effectively communicate the subject's status to the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain intensity from baseline to last assessment using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale. | weekly for 1 month during titration |
Secondary
| Measure | Time frame |
|---|---|
| Safety Assessment of Adverse Events, vital signs including oxygen saturation, Blood Pressure, and Heart Rate. | weekly for 1 month during titration |
Outcome results
None listed