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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.
Conditions
Interventions
SM-1
D+Z
+2 more
Locations
2
United States
NeuroTrials Research, Inc.
Atlanta, Georgia, United States
Clinilabs, Inc.
New York, New York, United States
Start Date
October 9, 2017
Primary Completion Date
March 20, 2018
Completion Date
March 22, 2018
Last Updated
June 5, 2019
NCT03338764
NCT00163046
NCT00659100
NCT00666770
NCT04396327
NCT00594022
Lead Sponsor
Sequential Medicine Ltd
Data Source & Attribution
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