Acute Cough Study In Children

• Sponsor: Pfizer (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01257542
• Collaborator: AccuDial Pharmaceutical, Inc. (Other), Boehringer Ingelheim (Industry), McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. (Industry), Novartis (Industry), Perrigo Company (Industry), Procter and Gamble (Industry), Reckitt Benckiser LLC (Industry)
• Enrollment: 140
• Locations: 4
• Arms: 2
• Duration (Months): 3
• Patients Per Site: 35
• Patients Per Site Per Month: 11.8

Study Details

Study Description

Brief Summary

15 mg dextromethorphan hydrobromide will be better than placebo with respect to reducing the number of coughs over 6 hours and reducing the subjective severity of cough over 6 hours.

Condition or Disease	Intervention/Treatment	Phase
Common Cold; Infections, Upper Respiratory Tract	Drug: Dextromethorphan; Drug: Placebo	Phase 4

Detailed Description

In light of protocol changes required due to methodological and operational issues, including background noise in cough recordings which could impact data interpretation, the study has been terminated.

Study Design

• Study Type: Interventional
• Actual Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Single-Dose, Pilot Study To Evaluate Efficacy Of Dextromethorphan Hydrobromide On Acute Cough In A Pediatric Population
• Study Start Date: Dec 1, 2010
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active	Drug: Dextromethorphan; A single 10 mL dose of Children's Triaminic Syrup (Dextromethorphan Hydrobromide 7.5 mg per 5 mL (total dose of 15 mg)
Placebo Comparator: Placebo	Drug: Placebo; A single 10 mL dose of matching placebo syrup

Outcome Measures

Primary Outcome Measures

1. Total Cough Count [Up to 6 hours post-dose]

   Total cough count was done by trained assessors using continuous digital video and audio recordings.

Secondary Outcome Measures

1. Change From Baseline in Perceived Verbal Cough Severity Scale for 6 Hour Post-Dose Period [Baseline, 1, 2, 3, 4, 5, 6 hours post-dose]

   Perceived verbal cough severity score was assessed on a 5-point categorical rating scale in accordance to the question "How much have you coughed in the last hour?", where 0 = not at all, 1 = a tiny bit, 2 = a little, 3 = some and 4 = a lot. The change from baseline over the 6-hour post-dosing period calculated as the average of change from baseline [that is (i.e.) baseline value minus the post baseline value] measurements of Hour 1 to Hour 6, thus the change from baseline ranged from -4 to 4; higher score indicated a better improvement.

2. Change From Baseline in Verbal Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6 [Baseline, 1, 2, 3, 4, 5, 6 hours]

   Verbal cough severity score was assessed on a 5-point categorical rating scale in accordance to the question "How much have you coughed in the last hour?", where 0 = not at all, 1 = a tiny bit, 2 = a little, 3 = some and 4 = a lot. The change from baseline values were derived by subtracting each post baseline value from the baseline value, and ranged from -4 to 4; higher score indicated a better improvement.

3. Change From Baseline in Perceived Numerical Cough Severity Scale for 6 Hour Post-Dose Period [Baseline, 1, 2, 3, 4, 5, 6 hour post-dose]

   Perceived numerical cough severity score was assessed on an 11-point categorical rating scale in accordance to the question "How much have you coughed in the last hour?", where 0 = did not cough at all and 10 = cough a lot. The change from baseline for the 6-hour post-dosing period was calculated as the average of change from baseline (i.e. baseline value minus the post baseline value) measurements of Hour 1 to Hour 6, thus the change from baseline values ranged from -10 to 10; higher score indicated a better improvement.

4. Change From Baseline in Numerical Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6 [Baseline, 1, 2, 3, 4, 5, 6 hours]

   Numerical cough severity score was assessed on an 11-point categorical rating scale in accordance to the question "How much have you coughed in the last hour?", wherein 0 = did not cough at all and 10 = cough a lot. The change from baseline was derived by subtracting the post baseline value from the baseline value and ranged from -10 to 10; higher score indicated a better improvement.

5. Participants' Global Assessment of Cough: Cough Severity [Within 5 minutes after Hour 6]

   Participant global assessment of cough with the assistance of parent or legal guardian was scored on a 5-point categorical scale based on response to the question " How much have you coughed in the past 6 hours?" where 0 = not at all, 1 = a tiny bit, 2 = a little, 3 = some and 4 = a lot.

6. Participants' Global Assessment of Cough: Relief From Cough [Within 5 minutes after Hour 6]

   Participant global assessment of cough with the assistance of parent or legal guardian was scored on a 5-point categorical scale based on response to the question "From when you woke up this morning until now, how much better is your cough?" where 0 = not at all better, 1 = a tiny bit better, 2 = a little better, 3 = better and 4 = a lot better.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 11 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Male or female healthy children ages 6 to under 12 years who are symptomatic with a cough due to a cold or acute URTI characterized by:

• Onset of cold/URTI symptoms occurring no more than 10 days prior to Visit 1;

• At least 5 coughs during the second 30-minute period of the 60-minute baseline period.

General good health, aside from a common cold, and has no contraindications to the study or rescue medication

Exclusion Criteria:

• Acute, subchronic, or chronic cough due to any other condition other than a common cold

History of clinically significant cardiovascular, pulmonary, hepatic, renal, neurological, hematological, autoimmune, psychiatric, metabolic, gastro-intestinal or endocrine disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	DMI Research	Pinellas	Florida	United States	33782-4533
2	Concentrics Center for Research	Indianapolis	Indiana	United States	46240
3	Cyn3rgy Research	Gresham	Oregon	United States	97030
4	Clinical Research Associates Incorporated	Nashville	Tennessee	United States	37203

Sponsors and Collaborators

• Pfizer
• AccuDial Pharmaceutical, Inc.
• Boehringer Ingelheim
• McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
• Novartis
• Perrigo Company
• Procter and Gamble
• Reckitt Benckiser LLC

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01257542
• Other Study ID Numbers: A6531001; RB-10-12
• First Posted: Dec 9, 2010
• Last Update Posted: Sep 20, 2012
• Last Verified: Aug 1, 2012

• Keywords provided by Pfizer: randomized; parallel; double-blind; placebo-controlled; cough; efficacy; safety; dextromethorphan
• Additional relevant MeSH terms: Common Cold; Respiratory Tract Infections; Dextromethorphan

Study Results

Participant Flow

Arm/Group Title	Placebo	Dextromethorphan Hydrobromide
Arm/Group Description	Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.	Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
Period Title: Overall Study
STARTED	55	52
COMPLETED	52	45
NOT COMPLETED	3	7

Baseline Characteristics

Arm/Group Title	Placebo	Dextromethorphan Hydrobromide	Total
Arm/Group Description	Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.	Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].	Total of all reporting groups
Overall Participants	55	52	107
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	8.9 (1.8)	8.9 (1.6)	8.9 (1.7)
Sex: Female, Male (Count of Participants)
Female	32 58.2%	25 48.1%	57 53.3%
Male	23 41.8%	27 51.9%	50 46.7%

Outcome Measures

1. Primary Outcome

Title	Total Cough Count
Description	Total cough count was done by trained assessors using continuous digital video and audio recordings.
Time Frame	Up to 6 hours post-dose

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.

Arm/Group Title	Placebo	Dextromethorphan Hydrobromide
Arm/Group Description	Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.	Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
Measure Participants	53	52
Mean (Standard Deviation) [Cough counts]	238.7 (252.3)	190.9 (190.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Dextromethorphan Hydrobromide
	Comments	Odds Ratio and corresponding 95 percent (%) confidence interval (CI) were assessed from the negative binomial regression model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.252
	Comments	p-value was calculated using negative binomial regression model with treatment, site and baseline of cough count terms with log (exposure time) as the offset parameter.
	Method	Negative binomial regression
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.83
	Confidence Interval	(2-Sided) 95%; 0.59 to 1.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change From Baseline in Perceived Verbal Cough Severity Scale for 6 Hour Post-Dose Period
Description	Perceived verbal cough severity score was assessed on a 5-point categorical rating scale in accordance to the question "How much have you coughed in the last hour?", where 0 = not at all, 1 = a tiny bit, 2 = a little, 3 = some and 4 = a lot. The change from baseline over the 6-hour post-dosing period calculated as the average of change from baseline [that is (i.e.) baseline value minus the post baseline value] measurements of Hour 1 to Hour 6, thus the change from baseline ranged from -4 to 4; higher score indicated a better improvement.
Time Frame	Baseline, 1, 2, 3, 4, 5, 6 hours post-dose

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.

Arm/Group Title	Placebo	Dextromethorphan Hydrobromide
Arm/Group Description	Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.	Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
Measure Participants	53	52
Baseline	3.0 (0.9)	2.9 (0.9)
Change for 6 hour post-dose period	1.3 (1.1)	1.1 (1.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Dextromethorphan Hydrobromide
	Comments	Treatment difference and corresponding 95% CI were calculated based on least-square (LS) means from analysis of variance (ANOVA) model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.134
	Comments	p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.26
	Confidence Interval	(2-Sided) 95%; -0.60 to 0.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Change From Baseline in Verbal Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6
Description	Verbal cough severity score was assessed on a 5-point categorical rating scale in accordance to the question "How much have you coughed in the last hour?", where 0 = not at all, 1 = a tiny bit, 2 = a little, 3 = some and 4 = a lot. The change from baseline values were derived by subtracting each post baseline value from the baseline value, and ranged from -4 to 4; higher score indicated a better improvement.
Time Frame	Baseline, 1, 2, 3, 4, 5, 6 hours

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.

Arm/Group Title	Placebo	Dextromethorphan Hydrobromide
Arm/Group Description	Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.	Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
Measure Participants	53	52
Change at 1 hour	1.0 (1.2)	0.9 (1.2)
Change at 2 hours	1.2 (1.2)	0.9 (1.4)
Change at 3 hours	1.3 (1.2)	0.9 (1.4)
Change at 4 hours	1.4 (1.3)	1.1 (1.4)
Change at 5 hours	1.7 (1.3)	1.2 (1.4)
Change at 6 hours	1.5 (1.4)	1.2 (1.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Dextromethorphan Hydrobromide
	Comments	1 hour: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.768
	Comments	p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.06
	Confidence Interval	(2-Sided) 95%; -0.45 to 0.33
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Dextromethorphan Hydrobromide
	Comments	2 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.358
	Comments	p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.20
	Confidence Interval	(2-Sided) 95%; -0.64 to 0.23
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Dextromethorphan Hydrobromide
	Comments	3 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.139
	Comments	p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.32
	Confidence Interval	(2-Sided) 95%; -0.74 to 0.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Dextromethorphan Hydrobromide
	Comments	4 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.364
	Comments	p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.21
	Confidence Interval	(2-Sided) 95%; -0.68 to 0.25
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Dextromethorphan Hydrobromide
	Comments	5 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.039
	Comments	p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.46
	Confidence Interval	(2-Sided) 95%; -0.90 to -0.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Dextromethorphan Hydrobromide
	Comments	6 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.206
	Comments	p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms.
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.29
	Confidence Interval	(2-Sided) 95%; -0.75 to 0.16
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Change From Baseline in Perceived Numerical Cough Severity Scale for 6 Hour Post-Dose Period
Description	Perceived numerical cough severity score was assessed on an 11-point categorical rating scale in accordance to the question "How much have you coughed in the last hour?", where 0 = did not cough at all and 10 = cough a lot. The change from baseline for the 6-hour post-dosing period was calculated as the average of change from baseline (i.e. baseline value minus the post baseline value) measurements of Hour 1 to Hour 6, thus the change from baseline values ranged from -10 to 10; higher score indicated a better improvement.
Time Frame	Baseline, 1, 2, 3, 4, 5, 6 hour post-dose

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.

Arm/Group Title	Placebo	Dextromethorphan Hydrobromide
Arm/Group Description	Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.	Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
Measure Participants	53	52
Baseline	6.8 (2.2)	7.0 (2.3)
Change for 6 hour post-dose period	2.8 (2.5)	2.5 (3.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Dextromethorphan Hydrobromide
	Comments	Treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.304
	Comments	p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.49
	Confidence Interval	(2-Sided) 95%; -1.43 to 0.45
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Change From Baseline in Numerical Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6
Description	Numerical cough severity score was assessed on an 11-point categorical rating scale in accordance to the question "How much have you coughed in the last hour?", wherein 0 = did not cough at all and 10 = cough a lot. The change from baseline was derived by subtracting the post baseline value from the baseline value and ranged from -10 to 10; higher score indicated a better improvement.
Time Frame	Baseline, 1, 2, 3, 4, 5, 6 hours

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.

Arm/Group Title	Placebo	Dextromethorphan Hydrobromide
Arm/Group Description	Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.	Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
Measure Participants	53	52
Change at 1 hour	2.0 (2.9)	2.0 (2.8)
Change at 2 hours	2.5 (2.6)	2.1 (3.5)
Change at 3 hours	2.7 (2.7)	2.3 (3.5)
Change at 4 hours	2.9 (2.8)	2.5 (3.6)
Change at 5 hours	3.6 (2.8)	3.0 (3.2)
Change at 6 hours	3.4 (3.3)	2.8 (3.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Dextromethorphan Hydrobromide
	Comments	1 hour: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.954
	Comments	p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.03
	Confidence Interval	(2-Sided) 95%; -1.03 to 0.97
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Dextromethorphan Hydrobromide
	Comments	2 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.426
	Comments	p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.44
	Confidence Interval	(2-Sided) 95%; -1.54 to 0.65
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Dextromethorphan Hydrobromide
	Comments	3 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.396
	Comments	p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.45
	Confidence Interval	(2-Sided) 95%; -1.49 to 0.60
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Dextromethorphan Hydrobromide
	Comments	4 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.402
	Comments	p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.49
	Confidence Interval	(2-Sided) 95%; -1.63 to 0.66
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Dextromethorphan Hydrobromide
	Comments	5 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.204
	Comments	p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.69
	Confidence Interval	(2-Sided) 95%; -1.75 to 0.38
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Dextromethorphan Hydrobromide
	Comments	6 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.179
	Comments	p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms.
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	-0.84
	Confidence Interval	(2-Sided) 95%; -2.06 to 0.39
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Participants' Global Assessment of Cough: Cough Severity
Description	Participant global assessment of cough with the assistance of parent or legal guardian was scored on a 5-point categorical scale based on response to the question " How much have you coughed in the past 6 hours?" where 0 = not at all, 1 = a tiny bit, 2 = a little, 3 = some and 4 = a lot.
Time Frame	Within 5 minutes after Hour 6

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.

Arm/Group Title	Placebo	Dextromethorphan Hydrobromide
Arm/Group Description	Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.	Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
Measure Participants	53	52
Mean (Standard Deviation) [Units on a scale]	3.1 (0.9)	3.0 (1.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Dextromethorphan Hydrobromide
	Comments	Treatment difference and the associated 95% CI were based on the weighted Gamma statistics.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.523
	Comments	p-value was calculated from the Cochran-Mantel-Haenszel (CMH) test with modified ridit scores controlling site.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.09
	Confidence Interval	(2-Sided) 95%; -0.21 to 0.39
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Participants' Global Assessment of Cough: Relief From Cough
Description	Participant global assessment of cough with the assistance of parent or legal guardian was scored on a 5-point categorical scale based on response to the question "From when you woke up this morning until now, how much better is your cough?" where 0 = not at all better, 1 = a tiny bit better, 2 = a little better, 3 = better and 4 = a lot better.
Time Frame	Within 5 minutes after Hour 6

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.

Arm/Group Title	Placebo	Dextromethorphan Hydrobromide
Arm/Group Description	Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.	Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
Measure Participants	53	52
Mean (Standard Deviation) [Units on a scale]	2.9 (1.0)	2.7 (1.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Dextromethorphan Hydrobromide
	Comments	Treatment difference and the associated 95% CI were based on the weighted Gamma statistics.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.796
	Comments	p-value was calculated from the CMH test with modified ridit scores controlling site.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.06
	Confidence Interval	(2-Sided) 95%; -0.35 to 0.24
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Placebo		Dextromethorphan Hydrobromide
Arm/Group Description	Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.		Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
All Cause Mortality
	Placebo		Dextromethorphan Hydrobromide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Dextromethorphan Hydrobromide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/55 (0%)		0/52 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Dextromethorphan Hydrobromide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/55 (7.3%)		6/52 (11.5%)
Gastrointestinal disorders
Nausea	0/55 (0%)		2/52 (3.8%)
Abdominal pain upper	1/55 (1.8%)		0/52 (0%)
Vomiting	0/55 (0%)		1/52 (1.9%)
General disorders
Pyrexia	2/55 (3.6%)		0/52 (0%)
Injury, poisoning and procedural complications
Limb injury	0/55 (0%)		1/52 (1.9%)
Skin laceration	0/55 (0%)		1/52 (1.9%)
Nervous system disorders
Headache	0/55 (0%)		3/52 (5.8%)
Dizziness	0/55 (0%)		1/52 (1.9%)
Respiratory, thoracic and mediastinal disorders
Choking	1/55 (1.8%)		0/52 (0%)

Limitations/Caveats

Due to methodological issues during study conduct, the study was terminated after only less than 50% of the targeted enrollment was achieved.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.