Last updated on October 2017

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

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Research Center For Clinical Studies-West, Inc.
Lancaster, CA United States
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Miami, FL United States
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Nicklaus Children's Hospital
Miami, FL United States
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Children's Hospital of Georgia
Augusta, GA United States
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Georgia Regents Medical Center Research Pharmacy
Augusta, GA United States
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Children's Hospital University of Illinois
Chicago, IL United States
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Pediatric Hematology-Oncology / Children's Hospital University
Chicago, IL United States
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Chicago, IL United States
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Pediatric Specialty Clinic
Royal Oak, MI United States
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William Beaumont Hospital
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UNC Hospitals
Chapel Hill, NC United States
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Chapel Hill, NC United States
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University of North Carolina at Chapel Hill
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East Carolina University Brody School of Medicine(ECU)
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Medical University of South Carolina, Investigational Drugs Services
Charleston, SC United States
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Charleston, SC United States
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San Antonio, TX United States
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Caguas, Puerto Rico
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