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

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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.

Trial design

32 participants in 1 patient group

ALO-02
Experimental group
Description:
One arm, open label, active
Treatment:
Drug: ALO-02

Trial documents
2

Trial contacts and locations

16

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Data sourced from clinicaltrials.gov

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