Status:
WITHDRAWN
Effectiveness, Safety, and Tolerability Study of Oxymorphone Immediate Release (IR) Oral Liquid in Opioid Tolerant Pediatric Subjects
Lead Sponsor:
Endo Pharmaceuticals
Conditions:
Chronic Pain
Eligibility:
All Genders
2-6 years
Phase:
PHASE3
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01206907
Start Date
October 1 2010
End Date
December 1 2013
Last Update
August 17 2012
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