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Induction, STabilization, Adherence, and Retention Trial (ISTART) - A Randomized, Non-inferiority, Multicenter Study to Assess Early Treatment Efficacy of OX219 Versus SUBOXONE Film and to Explore Switching Between Treatments

Trial Profile

Induction, STabilization, Adherence, and Retention Trial (ISTART) - A Randomized, Non-inferiority, Multicenter Study to Assess Early Treatment Efficacy of OX219 Versus SUBOXONE Film and to Explore Switching Between Treatments

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 May 2017

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At a glance

  • Drugs Buprenorphine/naloxone (Primary) ; Buprenorphine
  • Indications Opioid abuse
  • Focus Registrational; Therapeutic Use
  • Acronyms ISTART
  • Sponsors Orexo
  • Most Recent Events

    • 26 Sep 2015 Primary endpoint (The proportion of randomized subjects retained in treatment. at Day 15) has been met according to the results published in the Clinical Therapeutics.
    • 26 Sep 2015 Primary endpoint (The proportion of randomized subjects retained in treatment. at Day 3) has been met according to the results published in the Clinical Therapeutics.
    • 24 Sep 2015 Results published in the Clinical Therapeutics.
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