Last updated on February 2018

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


Brief description of study

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.

Detailed Study 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.

Clinical Study Identifier: NCT02680847

Contact Investigators or Research Sites near you

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Research Center For Clinical Studies-West, Inc.
Lancaster, CA United States

Shriners Hospitals For Children Northern California
Sacramento, CA United States

University of California Davis
Sacramento, CA United States

Children's Hospital University of Illinois
Chicago, IL United States

Pediatric Hematology-Oncology / Children's Hospital University
Chicago, IL United States

University of Illinois at Chicago Clinical Research Center
Chicago, IL United States

University of Illinois Hospital and Health Sciences System
Chicago, IL United States

University of Illinois Hospital at the Medical Center
Chicago, IL United States

East Carolina University Brody School of Medicine(ECU)
Greenville, NC United States

Leo Jenkins Cancer Center Pharmacy
Greenville, NC United States

Medical University of South Carolina, Investigational Drugs Services
Charleston, SC United States

Medical University of South Carolina, Rutledge Tower, Pediatric Clinic
Charleston, SC United States

Medical University of South Carolina, SCTR Research Nexus
Charleston, SC United States

Medical University of South Carolina Children's Hospital
Charleston, SC United States

Texas Association of Pediatric Neurology
Shavano Park, TX United States