drugset / Trial / NCT02062710

Antitussive Effect of a Naturally Flavored Syrup Containing Diphenhydramine, Compared With Dextromethorphan and Placebo

NCT02062710 ↗

Phase 4 Completed 22 enrolled Montefiore Medical Center
RandomizedCrossoverDouble-blindTreatment

Summary

The purpose of this study is to evaluate the antitussive (cough-suppressing) effects of two liquid medications: a combination of diphenhydramine and phenylephrine in a naturally cocoa flavoring, and, dextromethorphan syrup, compared with placebo.

Timeline

Start
2014-01
Primary completion
2014-06
Completion
2014-06

Outcome

Met primary endpoint

paper with pairwise analysis revealing a significant increase in mean log C5 (0.4 ± 0.55 (SD); p < 0.01) for the diphenhydramine-containing medication versus placebo. PMID 25673148 ↗

paper Our results provide the initial evidence of the ability of diphenhydramine to inhibit cough reflex sensitivity in subjects with acute pathological cough. PMID 25673148 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dextromethorphan Unknown 30 mg Oral
Subject Diphenhydramine Small molecule 25 mg Oral
Background Phenylephrine Small molecule 10 mg Oral

Indications

No indication recorded.