drugset
drugset / Trial / NCT02578186

Evaluation of Diphenhydramine Hydrochloride Effects in Subjects With Occasional Sleeplessness

NCT02578186 ↗

Phase 4 Completed 33 enrolled Procter and Gamble
RandomizedCrossoverQuadruple-blindTreatment

Summary

The present study was conducted to investigate the impact of diphenhydramine hydrochloride on the ability to initiate sleep.

Timeline

Start
2013-11
Primary completion
2014-12
Completion
2014-12

Outcome

Met primary endpoint

registry MEAN Diphenhydramine Hydrochloride: 19.1 (Standard Error 3.1) minutes NCT02578186 ↗

registry Diphenhydramine Hydrochloride vs Placebo; p = 0.0312; ANCOVA NCT02578186 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Diphenhydramine Small molecule 50 mg —

Indications

insomnia