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

Part of paid clinical trials in New York, New York.

Sponsor
Sequential Medicine Ltd
Study ID
NCT04396327
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Transient Insomnia

Eligibility Criteria

Sex
ALL
Age
25 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • SM-1 — DRUG
    diphenhydramine, zolpidem and lorazepam
  • Active Comparator — DRUG
    diphenhydramine and lorazepam

Study Details

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.

Key Dates

First listed
May 20, 2020
Start date
May 27, 2020
Status verified
Apr 2020
Primary completion
Jun 30, 2020
Completion
Jun 30, 2020

Study Design

Enrollment
14 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active Comparator: 2-Drug Combination
    50 mg diphenhydramine and 0.5 mg lorazepam
  • Experimental: Active Treatment: SM-1 3-Drug Combination
    3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam

Primary Outcome Measure

Latency to Persistent Sleep (LPS) [ Time Frame: 8 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Clinilabs Drug Development CorporationNew YorkNew York10019-

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Clinilabs Drug Development Corporation· New York, NY