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An Open-label Study To Evaluate The Pharmacokinetics And Safety Of Alo-02 (Oxycodone Hydrochloride And Naltrexone Hydrochloride) Extended-release Capsules In Children And Adolescents 7-17 Years Of Age Who Require Opioid Analgesia
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.
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.
Age
7 - 17 years
Sex
ALL
Healthy Volunteers
No
Research Center For Clinical Studies-West, Inc.
Lancaster, California, United States
Children's Hopsital Los Angeles
Los Angeles, California, United States
Children's Hospital Of Los Angeles - University Of Southern California School Of Medicine
Los Angeles, California, United States
Shriners Hospitals For Children Northern California
Sacramento, California, United States
UC Davis Health Attn: Peter Trovitch, PharmD
Sacramento, California, United States
University of California Davis
Sacramento, California, United States
University of Illinois at Chicago Clinical Research Center
Chicago, Illinois, United States
University of Illinois Hospital and Health Sciences Systems
Chicago, Illinois, United States
University of Illinois Hospital at the Medical Center
Chicago, Illinois, United States
East Carolina University Brody School of Medicine(ECU)
Greenville, North Carolina, United States
Start Date
January 21, 2016
Primary Completion Date
January 10, 2018
Completion Date
January 24, 2018
Last Updated
September 25, 2018
32
ACTUAL participants
ALO-02
DRUG
Lead Sponsor
Pfizer
Data Source & Attribution
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