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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


Phase 3
2 Years
6 Years
Not Enrolling
Both
Chronic Pain

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in pain intensity from baseline to last assessment using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale.

Outcome Time Frame:

weekly for 1 month during titration

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

EN3319-301

NCT ID:

NCT01206907

Start Date:

October 2010

Completion Date:

December 2013

Related Keywords:

  • Chronic Pain
  • sickle cell anemia
  • juvenile rheumatoid arthritis
  • burn victim
  • cancer
  • Chronic pain of malignant or non-malignant etiology

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