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Trial record 52 of 448 for:    diphenhydramine

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

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ClinicalTrials.gov Identifier: NCT02062710
Recruitment Status : Completed
First Posted : February 14, 2014
Results First Posted : April 28, 2015
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Peter Dicpinigaitis, Montefiore Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Cough Reflex Sensitivity Drug: 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 Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Antitussive Effect of a Naturally Flavored, Multi-Component Syrup Containing Diphenhydramine, Compared With Dextromethorphan and Placebo
Study Start Date : January 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014


Arm Intervention/treatment
Experimental: 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.

Drug: diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo
diphenhydramine 25 mg and phenylephrine 10 mg; dextromethorphan 30 mg; placebo.

Drug: diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan
diphenhydramine 25 mg and phenylephrine 10 mg; placebo; dextromethorphan 30 mg.

Drug: dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo
dextromethorphan 30 mg; diphenhydramine 25 mg and phenylephrine 10 mg; placebo

Drug: dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa
dextromethorphan 30 mg; placebo; diphenhydramine 25 mg and phenylephrine 10 mg

Drug: placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan
placebo; diphenhydramine 25 mg and phenylephrine 10 mg; dextromethorphan 30 mg

Drug: placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa
placebo; dextromethorphan 30 mg; diphenhydramine 25 mg and phenylephrine 10 mg

Experimental: 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.

Drug: diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo
diphenhydramine 25 mg and phenylephrine 10 mg; dextromethorphan 30 mg; placebo.

Drug: diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan
diphenhydramine 25 mg and phenylephrine 10 mg; placebo; dextromethorphan 30 mg.

Drug: dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo
dextromethorphan 30 mg; diphenhydramine 25 mg and phenylephrine 10 mg; placebo

Drug: dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa
dextromethorphan 30 mg; placebo; diphenhydramine 25 mg and phenylephrine 10 mg

Drug: placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan
placebo; diphenhydramine 25 mg and phenylephrine 10 mg; dextromethorphan 30 mg

Drug: placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa
placebo; dextromethorphan 30 mg; diphenhydramine 25 mg and phenylephrine 10 mg

Experimental: 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.
Drug: diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo
diphenhydramine 25 mg and phenylephrine 10 mg; dextromethorphan 30 mg; placebo.

Drug: diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan
diphenhydramine 25 mg and phenylephrine 10 mg; placebo; dextromethorphan 30 mg.

Drug: dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo
dextromethorphan 30 mg; diphenhydramine 25 mg and phenylephrine 10 mg; placebo

Drug: dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa
dextromethorphan 30 mg; placebo; diphenhydramine 25 mg and phenylephrine 10 mg

Drug: placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan
placebo; diphenhydramine 25 mg and phenylephrine 10 mg; dextromethorphan 30 mg

Drug: placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa
placebo; dextromethorphan 30 mg; diphenhydramine 25 mg and phenylephrine 10 mg

Experimental: 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.

Drug: diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo
diphenhydramine 25 mg and phenylephrine 10 mg; dextromethorphan 30 mg; placebo.

Drug: diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan
diphenhydramine 25 mg and phenylephrine 10 mg; placebo; dextromethorphan 30 mg.

Drug: dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo
dextromethorphan 30 mg; diphenhydramine 25 mg and phenylephrine 10 mg; placebo

Drug: dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa
dextromethorphan 30 mg; placebo; diphenhydramine 25 mg and phenylephrine 10 mg

Drug: placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan
placebo; diphenhydramine 25 mg and phenylephrine 10 mg; dextromethorphan 30 mg

Drug: placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa
placebo; dextromethorphan 30 mg; diphenhydramine 25 mg and phenylephrine 10 mg

Experimental: 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.
Drug: diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo
diphenhydramine 25 mg and phenylephrine 10 mg; dextromethorphan 30 mg; placebo.

Drug: diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan
diphenhydramine 25 mg and phenylephrine 10 mg; placebo; dextromethorphan 30 mg.

Drug: dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo
dextromethorphan 30 mg; diphenhydramine 25 mg and phenylephrine 10 mg; placebo

Drug: dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa
dextromethorphan 30 mg; placebo; diphenhydramine 25 mg and phenylephrine 10 mg

Drug: placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan
placebo; diphenhydramine 25 mg and phenylephrine 10 mg; dextromethorphan 30 mg

Drug: placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa
placebo; dextromethorphan 30 mg; diphenhydramine 25 mg and phenylephrine 10 mg

Experimental: 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.
Drug: diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo
diphenhydramine 25 mg and phenylephrine 10 mg; dextromethorphan 30 mg; placebo.

Drug: diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan
diphenhydramine 25 mg and phenylephrine 10 mg; placebo; dextromethorphan 30 mg.

Drug: dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo
dextromethorphan 30 mg; diphenhydramine 25 mg and phenylephrine 10 mg; placebo

Drug: dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa
dextromethorphan 30 mg; placebo; diphenhydramine 25 mg and phenylephrine 10 mg

Drug: placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan
placebo; diphenhydramine 25 mg and phenylephrine 10 mg; dextromethorphan 30 mg

Drug: placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa
placebo; dextromethorphan 30 mg; diphenhydramine 25 mg and phenylephrine 10 mg




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02062710


Locations
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United States, New York
Einstein Division/Montefiore Medical Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
Montefiore Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Peter Dicpinigaitis, Principal Investigator, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02062710     History of Changes
Other Study ID Numbers: MMC-IRB-13-10-170
First Posted: February 14, 2014    Key Record Dates
Results First Posted: April 28, 2015
Last Update Posted: February 28, 2018
Last Verified: February 2018

Keywords provided by Peter Dicpinigaitis, Montefiore Medical Center:
cough
cough reflex
capsaicin
diphenhydramine
phenylephrine
dextromethorphan
placebo

Additional relevant MeSH terms:
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Diphenhydramine
Promethazine
Sleep Aids, Pharmaceutical
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Phenylephrine
Oxymetazoline
Phenylpropanolamine
Chlorpheniramine, phenylpropanolamine drug combination
Dextromethorphan
Capsaicin
Guaifenesin
Antitussive Agents
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents