Trial Outcomes & Findings for Acute Cough Study In Children (NCT NCT01257542)
NCT ID: NCT01257542
Last Updated: 2012-09-20
Results Overview
Total cough count was done by trained assessors using continuous digital video and audio recordings.
TERMINATED
PHASE4
140 participants
Up to 6 hours post-dose
2012-09-20
Participant Flow
Participant milestones
| Measure |
Placebo
Single oral dose of placebo solution matched to 15 milligram (mg) \[10 milliliter (mL/)\] dextromethorphan hydrobromide.
|
Dextromethorphan Hydrobromide
Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup \[7.5 mg/5 milliliter (mL)\].
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
52
|
|
Overall Study
COMPLETED
|
52
|
45
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
Reasons for withdrawal
| Measure |
Placebo
Single oral dose of placebo solution matched to 15 milligram (mg) \[10 milliliter (mL/)\] dextromethorphan hydrobromide.
|
Dextromethorphan Hydrobromide
Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup \[7.5 mg/5 milliliter (mL)\].
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
5
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Acute Cough Study In Children
Baseline characteristics by cohort
| Measure |
Placebo
n=55 Participants
Single oral dose of placebo solution matched to 15 milligram (mg) \[10 milliliter (mL/)\] dextromethorphan hydrobromide.
|
Dextromethorphan Hydrobromide
n=52 Participants
Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup \[7.5 mg/5 milliliter (mL)\].
|
Total
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
8.9 Years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
8.9 Years
STANDARD_DEVIATION 1.6 • n=7 Participants
|
8.9 Years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 6 hours post-dosePopulation: Intent-to-treat (ITT) population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.
Total cough count was done by trained assessors using continuous digital video and audio recordings.
Outcome measures
| Measure |
Placebo
n=53 Participants
Single oral dose of placebo solution matched to 15 milligram (mg) \[10 milliliter (mL/)\] dextromethorphan hydrobromide.
|
Dextromethorphan Hydrobromide
n=52 Participants
Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup \[7.5 mg/5 milliliter (mL)\].
|
|---|---|---|
|
Total Cough Count
|
238.7 Cough counts
Standard Deviation 252.3
|
190.9 Cough counts
Standard Deviation 190.6
|
SECONDARY outcome
Timeframe: Baseline, 1, 2, 3, 4, 5, 6 hours post-dosePopulation: ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.
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.
Outcome measures
| Measure |
Placebo
n=53 Participants
Single oral dose of placebo solution matched to 15 milligram (mg) \[10 milliliter (mL/)\] dextromethorphan hydrobromide.
|
Dextromethorphan Hydrobromide
n=52 Participants
Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup \[7.5 mg/5 milliliter (mL)\].
|
|---|---|---|
|
Change From Baseline in Perceived Verbal Cough Severity Scale for 6 Hour Post-Dose Period
Baseline
|
3.0 Units on a scale
Standard Deviation 0.9
|
2.9 Units on a scale
Standard Deviation 0.9
|
|
Change From Baseline in Perceived Verbal Cough Severity Scale for 6 Hour Post-Dose Period
Change for 6 hour post-dose period
|
1.3 Units on a scale
Standard Deviation 1.1
|
1.1 Units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline, 1, 2, 3, 4, 5, 6 hoursPopulation: ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.
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.
Outcome measures
| Measure |
Placebo
n=53 Participants
Single oral dose of placebo solution matched to 15 milligram (mg) \[10 milliliter (mL/)\] dextromethorphan hydrobromide.
|
Dextromethorphan Hydrobromide
n=52 Participants
Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup \[7.5 mg/5 milliliter (mL)\].
|
|---|---|---|
|
Change From Baseline in Verbal Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6
Change at 1 hour
|
1.0 Units on a scale
Standard Deviation 1.2
|
0.9 Units on a scale
Standard Deviation 1.2
|
|
Change From Baseline in Verbal Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6
Change at 2 hours
|
1.2 Units on a scale
Standard Deviation 1.2
|
0.9 Units on a scale
Standard Deviation 1.4
|
|
Change From Baseline in Verbal Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6
Change at 3 hours
|
1.3 Units on a scale
Standard Deviation 1.2
|
0.9 Units on a scale
Standard Deviation 1.4
|
|
Change From Baseline in Verbal Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6
Change at 4 hours
|
1.4 Units on a scale
Standard Deviation 1.3
|
1.1 Units on a scale
Standard Deviation 1.4
|
|
Change From Baseline in Verbal Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6
Change at 5 hours
|
1.7 Units on a scale
Standard Deviation 1.3
|
1.2 Units on a scale
Standard Deviation 1.4
|
|
Change From Baseline in Verbal Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6
Change at 6 hours
|
1.5 Units on a scale
Standard Deviation 1.4
|
1.2 Units on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: Baseline, 1, 2, 3, 4, 5, 6 hour post-dosePopulation: ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.
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.
Outcome measures
| Measure |
Placebo
n=53 Participants
Single oral dose of placebo solution matched to 15 milligram (mg) \[10 milliliter (mL/)\] dextromethorphan hydrobromide.
|
Dextromethorphan Hydrobromide
n=52 Participants
Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup \[7.5 mg/5 milliliter (mL)\].
|
|---|---|---|
|
Change From Baseline in Perceived Numerical Cough Severity Scale for 6 Hour Post-Dose Period
Baseline
|
6.8 Units on a scale
Standard Deviation 2.2
|
7.0 Units on a scale
Standard Deviation 2.3
|
|
Change From Baseline in Perceived Numerical Cough Severity Scale for 6 Hour Post-Dose Period
Change for 6 hour post-dose period
|
2.8 Units on a scale
Standard Deviation 2.5
|
2.5 Units on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Baseline, 1, 2, 3, 4, 5, 6 hoursPopulation: ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.
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.
Outcome measures
| Measure |
Placebo
n=53 Participants
Single oral dose of placebo solution matched to 15 milligram (mg) \[10 milliliter (mL/)\] dextromethorphan hydrobromide.
|
Dextromethorphan Hydrobromide
n=52 Participants
Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup \[7.5 mg/5 milliliter (mL)\].
|
|---|---|---|
|
Change From Baseline in Numerical Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6
Change at 1 hour
|
2.0 Units on a scale
Standard Deviation 2.9
|
2.0 Units on a scale
Standard Deviation 2.8
|
|
Change From Baseline in Numerical Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6
Change at 2 hours
|
2.5 Units on a scale
Standard Deviation 2.6
|
2.1 Units on a scale
Standard Deviation 3.5
|
|
Change From Baseline in Numerical Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6
Change at 3 hours
|
2.7 Units on a scale
Standard Deviation 2.7
|
2.3 Units on a scale
Standard Deviation 3.5
|
|
Change From Baseline in Numerical Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6
Change at 4 hours
|
2.9 Units on a scale
Standard Deviation 2.8
|
2.5 Units on a scale
Standard Deviation 3.6
|
|
Change From Baseline in Numerical Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6
Change at 5 hours
|
3.6 Units on a scale
Standard Deviation 2.8
|
3.0 Units on a scale
Standard Deviation 3.2
|
|
Change From Baseline in Numerical Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6
Change at 6 hours
|
3.4 Units on a scale
Standard Deviation 3.3
|
2.8 Units on a scale
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Within 5 minutes after Hour 6Population: ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.
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.
Outcome measures
| Measure |
Placebo
n=53 Participants
Single oral dose of placebo solution matched to 15 milligram (mg) \[10 milliliter (mL/)\] dextromethorphan hydrobromide.
|
Dextromethorphan Hydrobromide
n=52 Participants
Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup \[7.5 mg/5 milliliter (mL)\].
|
|---|---|---|
|
Participants' Global Assessment of Cough: Cough Severity
|
3.1 Units on a scale
Standard Deviation 0.9
|
3.0 Units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Within 5 minutes after Hour 6Population: ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment.
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.
Outcome measures
| Measure |
Placebo
n=53 Participants
Single oral dose of placebo solution matched to 15 milligram (mg) \[10 milliliter (mL/)\] dextromethorphan hydrobromide.
|
Dextromethorphan Hydrobromide
n=52 Participants
Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup \[7.5 mg/5 milliliter (mL)\].
|
|---|---|---|
|
Participants' Global Assessment of Cough: Relief From Cough
|
2.9 Units on a scale
Standard Deviation 1.0
|
2.7 Units on a scale
Standard Deviation 1.3
|
Adverse Events
Placebo
Dextromethorphan Hydrobromide
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=55 participants at risk
Single oral dose of placebo solution matched to 15 milligram (mg) \[10 milliliter (mL/)\] dextromethorphan hydrobromide.
|
Dextromethorphan Hydrobromide
n=52 participants at risk
Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup \[7.5 mg/5 milliliter (mL)\].
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/55
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.
|
3.8%
2/52
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.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.8%
1/55
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.
|
0.00%
0/52
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.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/55
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.
|
1.9%
1/52
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.
|
|
General disorders
Pyrexia
|
3.6%
2/55
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.
|
0.00%
0/52
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.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/55
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.
|
1.9%
1/52
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.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/55
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.
|
1.9%
1/52
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.
|
|
Nervous system disorders
Headache
|
0.00%
0/55
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.
|
5.8%
3/52
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.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/55
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.
|
1.9%
1/52
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.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
1.8%
1/55
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.
|
0.00%
0/52
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER