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.
Phase of Trial: Phase III
Latest Information Update: 04 Apr 2018
At a glance
- Drugs Diphenhydramine/lorazepam/zolpidem (Primary) ; Diphenhydramine; Lorazepam; Zolpidem
- Indications Insomnia
- Focus Therapeutic Use
- Sponsors Sequential Medicine Ltd
- 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.