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

Pfizer

Status and phase: Terminated; Phase 4

Conditions: Moderate-severe Pain

Treatments: Drug: Ages 7-11; Drug: ages 12-17

Study type: Interventional

Funder types: Industry

Identifiers

NCT02101554

EMBEDA (Other Identifier)

B4541006

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 19 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

19 participants in 1 patient group

Embeda

Experimental group

Description:

One arm, open label, active

Treatment:

Drug: ages 12-17

Drug: Ages 7-11