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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02680847
Recruitment Status : Recruiting
First Posted : February 12, 2016
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 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
Estimated Primary Completion Date : January 20, 2019
Estimated Study Completion Date : January 20, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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.


Eligibility Criteria

Information from the National Library of Medicine

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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.
Contacts and Locations

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


Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

  Show 31 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

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: January 19, 2018
Last Verified: January 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