Phase 4 N=22 Randomized Double-blind Treatment

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

Cough Reflex Sensitivity

Bottom Line

View on ClinicalTrials.gov: NCT02062710 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2015

Primary outcome: Primary: Change in Cough Reflex Sensitivity to Capsaicin — 0.97; 0.80; 0.57 log C5 (uM)

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo (Drug); diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan (Drug); dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo (Drug); dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa (Drug); placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan (Drug); placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Montefiore Medical Center
Primary completion: Jun 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Cough Reflex Sensitivity to Capsaicin	0.97; 0.80; 0.57	—

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.

Eligibility Criteria

Inclusion Criteria

healthy adult nonsmokers
onset of acute, viral upper respiratory tract infection (common cold) within 72 hours of enrollment

Exclusion Criteria

smokers
history of asthma or other respiratory disorders

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02062710). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.