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Completed

NCT Number: NCT02062710

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

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.

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Key information

Conditions

Cough Reflex Sensitivity Cough Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Einstein Division/Montefiore Medical Center

The Bronx, New York, 10461, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo

Drug

diphenhydramine 25 mg and phenylephrine 10 mg; dextromethorphan 30 mg; placebo.

diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan

Drug

diphenhydramine 25 mg and phenylephrine 10 mg; placebo; dextromethorphan 30 mg.

dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo

Drug

dextromethorphan 30 mg; diphenhydramine 25 mg and phenylephrine 10 mg; placebo

dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa

Drug

dextromethorphan 30 mg; placebo; diphenhydramine 25 mg and phenylephrine 10 mg

placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan

Drug

placebo; diphenhydramine 25 mg and phenylephrine 10 mg; dextromethorphan 30 mg

placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa

Drug

placebo; dextromethorphan 30 mg; diphenhydramine 25 mg and phenylephrine 10 mg

Primary outcomes

  1. Change in Cough Reflex Sensitivity to Capsaicin

    Time frame: 2 hours after study drug administration

    increase in C5 (decrease in cough reflex sensitivity). Capsaicin cough challenge involves subjects breathing in incremental doubling concentrations of aerosolized capsaicin, 1 minute apart, until the concentration of capsaicin (micromolar) inducing 5 or more coughs (C5) is reached.

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 14, 2014
Registry last updated
Feb 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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