Safety and Pharmacokinetic Study of ALO-02 in Children Ages 7-17 With Pain

Pfizer

Status and phase

Terminated

Phase 4

Conditions

Moderate-severe Pain

Treatments

Drug: ALO-02

Study type

Interventional

Funder types

Industry

Identifiers

NCT02680847

ALO-02 PHASE 4 PEDIATRIC STUDY (Other Identifier)

B4531015

Details and patient eligibility

About

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

Full description

This is a multicenter, open-label, single-arm study designed to characterize the PK and to evaluate the safety of ALO-02 in children and adolescents 7 to 17 years of age who require opioid analgesia for moderate-to-severe pain. The study consists of 4 study periods (screening, titration, maintenance, follow-up) occurring over a period of up to 9 weeks. The study will enroll approximately 140 children and adolescents with at least 100 subjects once stabilized during the titration period to complete a minimum of 2 of the 4 weeks study duration in the maintenance period to satisfy the PK endpoint. A safety follow-up visit is required at 1 week post-last dose.

Enrollment

32 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 > 6 mg per day of oxycodone, 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.