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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

Tracking Information
First Submitted Date  ICMJE January 31, 2014
First Posted Date  ICMJE February 14, 2014
Results First Submitted Date  ICMJE September 16, 2014
Results First Posted Date  ICMJE April 28, 2015
Last Update Posted Date February 28, 2018
Study Start Date  ICMJE January 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 12, 2014)
Change in Cough Reflex Sensitivity to Capsaicin [ Time Frame: 2 hours after study drug administration ]
Change History Complete list of historical versions of study NCT02062710 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antitussive Effect of a Naturally Flavored Syrup Containing Diphenhydramine, Compared With Dextromethorphan and Placebo
Official Title  ICMJE Antitussive Effect of a Naturally Flavored, Multi-Component Syrup Containing Diphenhydramine, Compared With Dextromethorphan and Placebo
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cough Reflex Sensitivity
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.

    Interventions:
    • 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
  • 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.

    Interventions:
    • 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
  • 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.
    Interventions:
    • 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
  • 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.

    Interventions:
    • 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
  • 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.
    Interventions:
    • 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
  • 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.
    Interventions:
    • 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
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2014)
22
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02062710
Other Study ID Numbers  ICMJE MMC-IRB-13-10-170
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peter Dicpinigaitis, Montefiore Medical Center
Study Sponsor  ICMJE Montefiore Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Montefiore Medical Center
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP