NCT03331042View on ClinicalTrials.gov

SM-1 vs 2 Comparators and Placebo in Participants With a History of Transient Insomnia.

PHASE3CompletedINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

October 9, 2017

Primary Completion Date

March 20, 2018

Study Completion Date

March 22, 2018

Conditions
Transient Insomnia
Interventions
DRUG

SM-1

3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam.

DRUG

D+Z

2-drug combination comparator product containing 50-mg diphenhydramine and 5-mg delayed-release zolpidem.

DRUG

D+L

2-drug combination comparator product containing 50-mg diphenhydramine and 0.5-mg delayed-release lorazepam.

DRUG

Placebo

Identical in appearance to SM-1, D+Z and D+L and has the same excipients, but no diphenhydramine, zolpidem, lorazepam or delayed-release coating materials.

Trial Locations (2)

10019

Clinilabs, Inc., New York

30342

NeuroTrials Research, Inc., Atlanta

All Listed Sponsors
lead

Sequential Medicine Ltd

INDUSTRY

NCT03331042 - SM-1 vs 2 Comparators and Placebo in Participants With a History of Transient Insomnia. | Biotech Hunter | Biotech Hunter