Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
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.
Age
7–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Safety and Pharmacokinetic Study of EMBEDA in Children Ages 7-17 With Pain
