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 Pain Pediatric pain indication controlled release morphine Ages 7-11 ages 12-17 Embeda

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 Specialties in progress, not accepting new patients
    Orange California 92868 United States
  • University of California, Irvine Health-Inpatient Pharmacy in progress, not accepting new patients
    Orange California 92868 United States
  • University of California, Irvine Health-Medical Specialties in progress, not accepting new patients
    Orange California 92868 United States
  • Gottschalk Medical Plaza in progress, not accepting new patients
    Irvine California 92697 United States
  • UCI Medical Center- Outpatient Pharmacy in progress, not accepting new patients
    Orange California 92868 United 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