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An Investigational Study to Assess Efficacy and Pattern of Use of SM-1 in Subjects With a History of Transient Insomnia

NCT03338764 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2024-04-17

No results posted yet for this study

Summary

The purpose of this study is to assess the efficacy and pattern of use of the combination drug product SM-1 in adults who sometimes have difficulty in falling asleep or staying asleep, but who do not have chronic insomnia. Participants will receive SM-1 or placebo to take at home as needed over the course of 3 months treatment period.

Conditions

  • Transient Insomnia

Interventions

DRUG

SM-1

SM-1 3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam self-administered as needed to promote sleep

DRUG

Placebo

Identical in appearance to SM-1 and has the same excipients, but no active ingredients or delayed-release coating materials, self-administered as needed to promote sleep

Sponsors & Collaborators

  • Sequential Medicine Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-31
Primary Completion
2023-12-31
Completion
2023-12-31
FDA Drug
Yes

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Entities

Drugs

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 NCT03338764 on ClinicalTrials.gov