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A Randomized, Double-blind, Double-dummy, Placebo Controlled, Single-Dose, 6-Way Crossover Study to Determine the Relative Abuse Potential of ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules) Compared to Oxycodone Immediate Release and Placebo When Administered Orally to Non-Dependent, Recreational Opioid Users

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A Randomized, Double-blind, Double-dummy, Placebo Controlled, Single-Dose, 6-Way Crossover Study to Determine the Relative Abuse Potential of ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules) Compared to Oxycodone Immediate Release and Placebo When Administered Orally to Non-Dependent, Recreational Opioid Users

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 19 Dec 2018

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At a glance

  • Drugs Oxycodone/naltrexone (Primary) ; Oxycodone
  • Indications Pain
  • Focus Pharmacodynamics
  • Sponsors Pfizer

    • Most Recent Events

    • 03 May 2014 Primary endpoints 'drug liking and high measured on visual analog scales, reported as Emax and AUE0-2h from 0 to 2 hours' has been met as per the results presented at the 33rd Annual Scientific Meeting of the American Pain Society.
    • 03 May 2014 Results presented at the 33rd Annual Scientific Meeting of the American Pain Society.
    • 01 Aug 2013 Status changed from recruiting to completed as reported by ClinicalTrials.gov.

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