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

NCT ID: NCT02062710

Last Updated: 2018-02-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Cough Reflex Sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A, B, then C

Subjects received the following: Period 1: single oral dose of diphenhydramine 25 mg and phenylephrine 10 mg, in naturally-flavored cocoa syrup (treatment A). Period 2: dextromethorphan syrup 30 mg (treatment B); Period 3: placebo liquid, dextrose in water, 20 mL (treatment C).

Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.Each dosing period separated by 1-2 day washout period.

Group Type EXPERIMENTAL

diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo

Intervention Type DRUG

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

diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan

Intervention Type DRUG

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

dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo

Intervention Type DRUG

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

dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa

Intervention Type DRUG

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

placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan

Intervention Type DRUG

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

placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa

Intervention Type DRUG

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

A, C, then B

Subjects received the following: Period 1: single oral doce of diphenhydramine 25 mg and phenylephrine 10 mg, in naturally-flavored cocoa syrup (treatment A); Period 2: placebo liquid, dextrose in watwer, 20 mL (treatment C); Period 3: dextromethorphan syrup 30 mg (treatment B).

Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.Each dosing period separated by 1-2 day washout period.

Group Type EXPERIMENTAL

diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo

Intervention Type DRUG

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

diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan

Intervention Type DRUG

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

dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo

Intervention Type DRUG

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

dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa

Intervention Type DRUG

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

placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan

Intervention Type DRUG

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

placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa

Intervention Type DRUG

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

B, A, then C

Subjects received the following: Period 1: dextromethorphan syrup 30 mg (treatment B); Period 2: single dose of oral diphenhydramine 25 mg and phenylephrine 10 mg, in a naturally-flavored cocoa syrup (treatment A); Period 3: placebo liquid, dextrose in water, 20 mL (treatment C). Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period.

Group Type EXPERIMENTAL

diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo

Intervention Type DRUG

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

diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan

Intervention Type DRUG

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

dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo

Intervention Type DRUG

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

dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa

Intervention Type DRUG

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

placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan

Intervention Type DRUG

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

placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa

Intervention Type DRUG

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

B, C, then A

Subjects received the following: Period 1: dextromethorphan 30 mg syrup (treatment B); Period 2: placebo liquid, dextrose in water, 20 mL (treatment C); Period 3: single dose of oral diphenhydramine 25 mg and phenylephrine 10 mg in a naturally-flavored cocoa syrup (treatment A).

Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period.

Group Type EXPERIMENTAL

diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo

Intervention Type DRUG

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

diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan

Intervention Type DRUG

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

dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo

Intervention Type DRUG

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

dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa

Intervention Type DRUG

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

placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan

Intervention Type DRUG

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

placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa

Intervention Type DRUG

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

C, A, then B

Subjects received the following: Period 1: placebo liquid, dextrose in water, 20 mL (treatment C); Period 2: a single oral dose of diphenhydramine 25 mg and phenylephrine 10 mg in a naturally-flavored cocoa syrup (treatment A); Period 3: dextromethorphan 30 mg syrup (treatment B). Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period.

Group Type EXPERIMENTAL

diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo

Intervention Type DRUG

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

diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan

Intervention Type DRUG

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

dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo

Intervention Type DRUG

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

dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa

Intervention Type DRUG

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

placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan

Intervention Type DRUG

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

placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa

Intervention Type DRUG

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

C, B, then A

Subjects received the following: Period 1: placebo liquid, dextrose in water, 20 mL (treatment C); Period 2: dextromethorphan 30 mg syrup (treatment B); Period 3: a single oral dose of diphenhydramine 25 mg and phenylephrine 10 mg in a naturally-flavored cocoa syrup (treatment A). Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion. Each dosing period separated by 1-2 day washout period.

Group Type EXPERIMENTAL

diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo

Intervention Type DRUG

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

diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan

Intervention Type DRUG

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

dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo

Intervention Type DRUG

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

dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa

Intervention Type DRUG

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

placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan

Intervention Type DRUG

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

placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa

Intervention Type DRUG

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

Interventions

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diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo

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

Intervention Type DRUG

diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan

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

Intervention Type DRUG

dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo

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

Intervention Type DRUG

dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa

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

Intervention Type DRUG

placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan

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

Intervention Type DRUG

placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Peter Dicpinigaitis

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Einstein Division/Montefiore Medical Center

The Bronx, New York, United States

Site Status

Countries

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United States

References

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Dicpinigaitis PV, Dhar S, Johnson A, Gayle Y, Brew J, Caparros-Wanderley W. Inhibition of cough reflex sensitivity by diphenhydramine during acute viral respiratory tract infection. Int J Clin Pharm. 2015 Jun;37(3):471-4. doi: 10.1007/s11096-015-0081-8. Epub 2015 Feb 12.

Reference Type DERIVED
PMID: 25673148 (View on PubMed)

Other Identifiers

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MMC-IRB-13-10-170

Identifier Type: -

Identifier Source: org_study_id

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