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

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ClinicalTrials.gov Identifier: NCT02680847
Recruitment Status : Terminated (The trial was terminated on 08FEB2018. Pfizer has decided to withdraw the New Drug Application and has notified FDA. There are no efficacy or safety concerns.)
First Posted : February 12, 2016
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Moderate-severe Pain Drug: ALO-02 Phase 4

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 21, 2016
Actual Primary Completion Date : January 10, 2018
Actual Study Completion Date : January 23, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: ALO-02
One arm, open label, active
Drug: ALO-02
Oral/Capsule, twice per day dosing; Treatment duration consists of a 1 to 4 week Conversion/Titration Phase leading to a 2 to 4 week Maintenance Treatment duration.
Other Name: oxycodone hydrochloride/naltrexone hydrochloride



Primary Outcome Measures :
  1. Adverse Events [ Time Frame: Daily for up to 11 weeks ]
    Incidence, intensity, relationship, and seriousness of adverse events (including symptoms of opioid withdrawal or overdose).

  2. Apparent Oral Clearance [ Time Frame: 2 - 3 weeks post first dose ]
    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.

  3. Css,av [ Time Frame: 2 - 3 weeks post first dose ]
    Css,av is the average steady state concentration of a drug ("steady state" has been achieved when the rate of drug administration and the rate of drug elimination are equal).


Secondary Outcome Measures :
  1. Apparent volume of distribution (Vz/F) [ Time Frame: 2 - 3 weeks post first dose ]
    Apparent volume of distribution (Vz/F) of oxycodone, data permitting; and systemic exposure levels of the metabolites of oxycodone (oxymorphone and noroxycodone), naltrexone, and 6-β-naltrexol.



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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02680847


Locations
United States, California
Research Center For Clinical Studies-West, Inc.
Lancaster, California, United States, 93534
Chidlren's Hospital Los Angeles
Los Angeles, California, United States, 90027
Children's Hospital Of Los Angeles - University Of Southern California School Of Medicine
Los Angeles, California, United States, 90027
Shriners Hospitals For Children Northern California
Sacramento, California, United States, 95817
University of California Davis
Sacramento, California, United States, 95817
United States, Illinois
Children's Hospital University of Illinois
Chicago, Illinois, United States, 60612
Pediatric Hematology-Oncology / Children's Hospital University
Chicago, Illinois, United States, 60612
University of Illinois at Chicago Clinical Research Center
Chicago, Illinois, United States, 60612
University of Illinois Hospital and Health Sciences System
Chicago, Illinois, United States, 60612
University of Illinois Hospital at the Medical Center
Chicago, Illinois, United States, 60612
United States, North Carolina
East Carolina University Brody School of Medicine(ECU)
Greenville, North Carolina, United States, 27834
Leo Jenkins Cancer Center Pharmacy
Greenville, North Carolina, United States, 27834
United States, South Carolina
Medical University of South Carolina Children's Hospital
Charleston, South Carolina, United States, 29425
Medical University of South Carolina, Investigational Drugs Services
Charleston, South Carolina, United States, 29425
Medical University of South Carolina, Rutledge Tower, Pediatric Clinic
Charleston, South Carolina, United States, 29425
Medical University of South Carolina, SCTR Research Nexus
Charleston, South Carolina, United States, 29425
United States, Texas
Texas Association of Pediatric Neurology
Shavano Park, Texas, United States, 78249
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02680847     History of Changes
Other Study ID Numbers: B4531015
ALO-02 PHASE 4 PEDIATRIC STUDY ( Other Identifier: Alias Study Number )
First Posted: February 12, 2016    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
Pediatric
pain indication
controlled release oxycodone

Additional relevant MeSH terms:
Naltrexone
Oxycodone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics