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

• Status: Terminated
• Trial end date: 2019-06-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

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.