Summary

for people ages 7-17 (full criteria)
at Orange, California and other locations
study started
estimated completion

Description

Summary

Safety and pharmacokinetics of an abuse-deterrent, extended-release formulation of morphine sulfate with a sequestered naltrexone core in children 7-17 with moderate-severe pain.

Official Title

AN OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETICS OF PF-06412528 IN CHILDREN 7-17 YEARS FOR THE TREATMENT OF MODERATE-TO-SEVERE PAIN

Details

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.

Keywords

Moderate-severe PainPediatricpain indicationcontrolled release morphineAges 7-11ages 12-17Embeda

Eligibility

You can join if…

Open to people ages 7-17

  • 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 CAN'T join 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.

Locations

  • The University of California, Irvine Health - Medical Specialtiesin progress, not accepting new patients
    OrangeCalifornia92868United States
  • University of California, Irvine Health-Inpatient Pharmacyin progress, not accepting new patients
    OrangeCalifornia92868United States
  • University of California, Irvine Health-Medical Specialtiesin progress, not accepting new patients
    OrangeCalifornia92868United States
  • Gottschalk Medical Plazain progress, not accepting new patients
    IrvineCalifornia92697United States
  • UCI Medical Center- Outpatient Pharmacyin progress, not accepting new patients
    OrangeCalifornia92868United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT02101554
Phase
Phase 4
Study Type
Interventional
Last Updated