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Clinical trial

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.

NCT03331042 is registered in ClinicalTrials.gov with Sequential Medicine Ltd as lead sponsor.

NCT NCT03331042
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Registry record

As filed in ClinicalTrials.gov.

Title
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.
Lead sponsor
Sequential Medicine Ltd
Phase
Phase 3
Overall status
Completed
Start date
October 9, 2017
Completion date
March 22, 2018
Enrollment
85 (actual)
Sites
2

Conditions

As the registry lists them; a condition with its own page is linked.

transient insomnia