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A Randomized, Double-Blind, Single-Dose, 4-Way Crossover Study to Assess the Efficacy and Safety of SM-1 (50-mg Diphenhydramine, 5-mg Delayed-Release Zolpidem, and 0.5-mg Delayed-Release Lorazepam) Versus 2 Comparators (50-mg Diphenhydramine and 5-mg Delayed-Release Zolpidem; 50-mg Diphenhydramine and 0.5-mg Delayed-Release Lorazepam) and Placebo in a 5-Hour Phase Advance Model of Transient Insomnia.

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Trial Profile

A Randomized, Double-Blind, Single-Dose, 4-Way Crossover Study to Assess the Efficacy and Safety of SM-1 (50-mg Diphenhydramine, 5-mg Delayed-Release Zolpidem, and 0.5-mg Delayed-Release Lorazepam) Versus 2 Comparators (50-mg Diphenhydramine and 5-mg Delayed-Release Zolpidem; 50-mg Diphenhydramine and 0.5-mg Delayed-Release Lorazepam) and Placebo in a 5-Hour Phase Advance Model of Transient Insomnia.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Jun 2019

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At a glance

  • Drugs Diphenhydramine/lorazepam/zolpidem (Primary) ; Diphenhydramine; Lorazepam; Zolpidem
  • Indications Insomnia
  • Focus Therapeutic Use
  • Sponsors Sequential Medicine Ltd

    • Most Recent Events

    • 28 Mar 2018 Status changed from active, no longer recruiting to completed.
    • 05 Mar 2018 Status changed from recruiting to active, no longer recruiting.
    • 27 Feb 2018 Planned number of patients changed from 68 to 84.
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