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SM-1 vs. an Active Comparator in A Model of Transient Insomnia

NCT04396327 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2020-05-20

No results posted yet for this study

Summary

The purpose of this study is to investigate the effectiveness, safety and tolerability of a combination drug product (SM-1) containing diphenhydramine, zolpidem and lorazepam, in adult participants who sometimes have difficulty in falling asleep or staying asleep, but who do not have chronic insomnia. Participants will receive SM-1 or a combination of diphenhydramine and lorazepam during 2 one-night stays at a sleep center.

Conditions

  • Transient Insomnia

Interventions

DRUG

SM-1

diphenhydramine, zolpidem and lorazepam

DRUG

Active Comparator

diphenhydramine and lorazepam

Sponsors & Collaborators

  • Sequential Medicine Ltd

    lead INDUSTRY

Principal Investigators

  • Maha Ahmad, MD, MMSc · Clinilabs Drug Development Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-27
Primary Completion
2020-06-30
Completion
2020-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04396327 on ClinicalTrials.gov