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Pilot Study of a Combination Drug Product for Treatment of Short-term Insomnia

NCT02671760 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2018-03-06

Study results available
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Summary

The purpose of this study is to evaluate the effect of a combination drug product containing diphenhydramine, zolpidem and lorazepam on total sleep time. Participants will be adults who sometimes have difficulty falling asleep or staying asleep, but who do not have chronic insomnia. The study involves 3 one-night stays in a sleep center in New York City.

Conditions

  • Short-term Insomnia

Interventions

DRUG

SM-1

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

DRUG

Comparator

2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Clinilabs, Inc.

    collaborator OTHER

  • Sequential Medicine Ltd

    lead INDUSTRY

Principal Investigators

  • Thomas Dahl, PhD · Sequential Medicine Ltd

  • Maha Ahamad, MD · Clinilabs, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
25 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2016-06-30
Completion
2016-06-30

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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 NCT02671760 on ClinicalTrials.gov