Trial · NCT01257542
Acute Cough Study In Children
NCT01257542, Phase 4, Terminated, Pfizer; results first posted 2012-09-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Acute Cough Study In Children. Trials, record NCT01257542. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01257542
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Acute Cough Study In Children
- NCT number
- NCT01257542
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 140 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Common Cold, Infections, Upper Respiratory Tract
- Interventions
- Dextromethorphan, Placebo
- First posted
- 2010-12-09
- Last updated
- 2012-09-20
- Results first posted
- 2012-09-20
- Limitations and caveats
- Due to methodological issues during study conduct, the study was terminated after only less than 50% of the targeted enrollment was achieved.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Total Cough Count | Up to 6 hours post-dose | Intent-to-treat (ITT) population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment. | Cough counts | MEAN |
| SECONDARY | 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 | ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment. | Units on a scale | MEAN |
| SECONDARY | 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 | ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment. | Units on a scale | MEAN |
| SECONDARY | 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 | ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment. | Units on a scale | MEAN |
| SECONDARY | 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 | ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment. | Units on a scale | MEAN |
| SECONDARY | Participants' Global Assessment of Cough: Cough Severity | Within 5 minutes after Hour 6 | ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment. | Units on a scale | MEAN |
| SECONDARY | Participants' Global Assessment of Cough: Relief From Cough | Within 5 minutes after Hour 6 | ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment. | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Cough Count | Placebo | 238.7 | Standard Deviation 252.3 | Cough counts | |
| Total Cough Count | Dextromethorphan Hydrobromide | 190.9 | Standard Deviation 190.6 | Cough counts | |
| Change From Baseline in Perceived Verbal Cough Severity Scale for 6 Hour Post-Dose Period | Placebo | Baseline | 3.0 | Standard Deviation 0.9 | Units on a scale |
| Change From Baseline in Perceived Verbal Cough Severity Scale for 6 Hour Post-Dose Period | Dextromethorphan Hydrobromide | Baseline | 2.9 | Standard Deviation 0.9 | Units on a scale |
| Change From Baseline in Perceived Verbal Cough Severity Scale for 6 Hour Post-Dose Period | Placebo | Change for 6 hour post-dose period | 1.3 | Standard Deviation 1.1 | Units on a scale |
| Change From Baseline in Perceived Verbal Cough Severity Scale for 6 Hour Post-Dose Period | Dextromethorphan Hydrobromide | Change for 6 hour post-dose period | 1.1 | Standard Deviation 1.1 | Units on a scale |
| Change From Baseline in Verbal Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6 | Placebo | Change at 1 hour | 1.0 | Standard Deviation 1.2 | Units on a scale |
| Change From Baseline in Verbal Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6 | Dextromethorphan Hydrobromide | Change at 1 hour | 0.9 | Standard Deviation 1.2 | Units on a scale |
| Change From Baseline in Verbal Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6 | Placebo | Change at 2 hours | 1.2 | Standard Deviation 1.2 | Units on a scale |
| Change From Baseline in Verbal Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6 | Dextromethorphan Hydrobromide | Change at 2 hours | 0.9 | Standard Deviation 1.4 | Units on a scale |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 55 | |
| Overall Study | STARTED | Dextromethorphan Hydrobromide | 52 | |
| Overall Study | COMPLETED | Placebo | 52 | |
| Overall Study | COMPLETED | Dextromethorphan Hydrobromide | 45 | |
| Overall Study | NOT COMPLETED | Placebo | 3 | |
| Overall Study | NOT COMPLETED | Dextromethorphan Hydrobromide | 7 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Placebo | 0 | 55 | |
| other | Nausea | Gastrointestinal disorders | Dextromethorphan Hydrobromide | 2 | 52 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 1 | 55 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Dextromethorphan Hydrobromide | 0 | 52 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 0 | 55 | |
| other | Vomiting | Gastrointestinal disorders | Dextromethorphan Hydrobromide | 1 | 52 | |
| other | Pyrexia | General disorders | Placebo | 2 | 55 | |
| other | Pyrexia | General disorders | Dextromethorphan Hydrobromide | 0 | 52 | |
| other | Limb injury | Injury, poisoning and procedural complications | Placebo | 0 | 55 | |
| other | Limb injury | Injury, poisoning and procedural complications | Dextromethorphan Hydrobromide | 1 | 52 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Dextromethorphan Hydrobromide | ||
| Total, other adverse events | Placebo | 4 | 55 |
| Total, other adverse events | Dextromethorphan Hydrobromide | 6 | 52 |
| Total, serious adverse events | Placebo | 0 | 55 |
| Total, serious adverse events | Dextromethorphan Hydrobromide | 0 | 52 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Dextromethorphan Hydrobromide vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01257542
GET https://conductscience.org/api/trials/v1/NCT01257542/results?page=2