Safety and Pharmacokinetic Study of EMBEDA in Children Ages 7-17 With Pain

Launched by PFIZER · Mar 28, 2014

Keywords

ClinConnect Summary

Subjects, once stabilized to Embeda, need only complete a minimum of 2 of the 6 week study duration to satisfy the PK endpoint. A safety follow-up visit is required at 1 week post-last dose.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Children 7-17 with moderate to severe pain requiring around the clock treatment with an opioid analgesic.
• • Be an experienced opioid user, defined as any subject treated with opioid therapy, equivalent or equal to \>20 mg per day of morphine, for a period of 3 consecutive days immediately prior to first day of dosing.
• Exclusion Criteria:
• • Columbia-Suicide Severity Rating Scale (C-SSRS) for suicidal ideation and behavior in past year.
• • Hypersensitivity to morphine, naltrexone.
• • A life expectancy (assessed by investigator) of less than 6 months or is no longer capable of taking medication orally.
• • Undergone surgery within 3 days prior to the first day of dosing.