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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Cough Reflex Sensitivity
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
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Diphenhydramine/Phen/Cocoa, Dextromethorphan, Then Placebo Diphenhydramine/Phenylephrine/Cocoa, Then Placebo, Then Dextro Dextromethorphan, Diphenhydramine/Phenylephrine/Cocoa, Then pl Dextromethorphan, Placebo, Then Diphenhydramine/Phenylephrine/ Placebo, Diphenhydramine/Phenylephrine/Cocoa, Then Dextrometho Placebo, Dextromethorphan, Then Diphenhydramine/Phenylephrine/
Hide Arm/Group Description

Diphenhydramine 25 mg, phenylephrine 10 mg, in naturally-flavored cocoa syrup; then dextromethorphan 30 mg; then placebo.

Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.

Washout 1-2 days between each of the 3 dosing periods.

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

Intervention: capsaicin cough challenge testing after study drug ingestion

dextromethorphan 30 mg, then diphenhydramine/phenylephrine/cocoa, then placebo. Intervention: capsaicin cough challeneg 2 hours after study drug ingestion

dextromethorphan 30 mg, then placebo, then diphenhydramine 25 mg and phenylephrine 10 mg.

Intervention: capsaicin cough challenge 2 hours after study drug ingestion. Washout period 1-2 days between each of the 3 dosing periods

placebo, then diphenhydramine 25 mg and phenylephrine 10 mg, then dextromethorphan 30 mg.

Intervention: capsaicin cough challenge 2 hours after study drug administration.

Washout period 1-2 days after each of the 3 dosing periods

placebo, then dextromethorphan 30 mg, then diphenhydramine 25 mg and phenylephrine 10 mg.

Intervention: capsaicin cough challenge 2 hours after study drug administration.

Washout period 1-2 days after each of the 3 dosing periods.

Period Title: Overall Study
Started 3 [1] 4 [2] 5 [3] 3 [4] 3 [5] 4 [6]
Completed 3 4 5 3 3 4
Not Completed 0 0 0 0 0 0
[1]
3 of total 22 subjects randomized to receive the 3 study drugs in this particular sequence
[2]
4 of the total 22 subjects randomized to receive the 3 study drugs in this particular sequence
[3]
5 of total of 22 subjects randomized to receive the 3 study drugs in this particular sequence
[4]
3 of 22 subjects randomized to receive the 3 study drugs in this particular sequence
[5]
3 of 22 subjects randomized to receive the 3 study drugs in this aprticular sequence
[6]
4 of 22 subjects randomized to receive the 3 study drugs in this particular sequence
Arm/Group Title Diphenhydramine/Phenylephrine/Cocoa, Dextromethorphan,Placebo
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Diphenhydramine 25 mg, phenylephrine 10 mg, in naturally-flavored cocoa syrup; dextromethorphan; placebo.

Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.

Phenylephrine: 10 mg dose phenylephrine

Diphenhydramine: 25 mg dose diphenhydramine

Dextromethorphan: 30 mg dose dextromethorphan

Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
<=18 years
0
   0.0%
Between 18 and 65 years
22
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
16
  72.7%
Male
6
  27.3%
1.Primary Outcome
Title Change in Cough Reflex Sensitivity to Capsaicin
Hide Description 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.
Time Frame 2 hours after study drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Diphenhydramine/Phenylephrine/Cocoa Dextromethorphan Placebo
Hide Arm/Group Description:

Diphenhydramine 25 mg, phenylephrine 10 mg, in naturally-flavored cocoa syrup. Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.

Phenylephrine: 10 mg dose phenylephrine

Diphenhydramine: 25 mg dose diphenhydramine

Dextromethorphan syrup, 30 mg dose. Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.

Dextromethorphan: 30 mg dose dextromethorphan

placebo liquid, dextrose in water, 20 mL
Overall Number of Participants Analyzed 22 22 22
Mean (Standard Error)
Unit of Measure: log C5 (uM)
0.97  (0.16) 0.80  (0.18) 0.57  (0.16)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diphenhydramine/Phenylephrine/Cocoa Dextromethorphan Placebo
Hide Arm/Group Description

Diphenhydramine 25 mg, phenylephrine 10 mg, in naturally-flavored cocoa syrup. Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.

Phenylephrine: 10 mg dose phenylephrine

Diphenhydramine: 25 mg dose diphenhydramine

Dextromethorphan syrup, 30 mg dose. Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.

Dextromethorphan: 30 mg dose dextromethorphan

placebo liquid, dextrose in water, 20 mL
All-Cause Mortality
Diphenhydramine/Phenylephrine/Cocoa Dextromethorphan Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Diphenhydramine/Phenylephrine/Cocoa Dextromethorphan Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/22 (0.00%)   0/22 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Diphenhydramine/Phenylephrine/Cocoa Dextromethorphan Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/22 (0.00%)   0/22 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Peter Dicpinigaitis, MD
Organization: Montefiore Medcial Center
Phone: 718-904-2676
EMail: pdicpini@montefiore.org
Layout table for additonal information
Responsible Party: Peter Dicpinigaitis, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02062710     History of Changes
Other Study ID Numbers: MMC-IRB-13-10-170
First Submitted: January 31, 2014
First Posted: February 14, 2014
Results First Submitted: September 16, 2014
Results First Posted: April 28, 2015
Last Update Posted: February 28, 2018