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

Stopped early · Phase 4

Conditions studied: Moderate-severe Pain

In brief

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.

Key facts

Study ID

NCT02680847

Run by

Pfizer

People needed

32

Starts

2016-01-21

Expected to finish

2018-01-24

Last updated by the study team

2018-09-25

Who can join

Age: 7 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Leo Jenkins Cancer Center Pharmacy — Greenville, North Carolina, United States
• Medical University of South Carolina Children's Hospital — Charleston, South Carolina, United States
• Medical University of South Carolina, Investigational Drugs Services — Charleston, South Carolina, United States
• Medical University of South Carolina, Rutledge Tower, Pediatric Clinic — Charleston, South Carolina, United States
• Medical University of South Carolina, SCTR Research Nexus — Charleston, South Carolina, United States
• Road Runner Research, Ltd — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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