Common ColdPhase 4NCT01257542
Acute Cough Study In Children
A Phase 4 study testing Dextromethorphan in people with Common Cold and Infections, Upper Respiratory Tract, run by Pfizer at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Common Cold, Infections, Upper Respiratory Tract
- What is being tested?
- Dextromethorphan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2010to Mar 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Cyn3rgy Research
Gresham, Oregon, 97030
Concentrics Center for Research
Indianapolis, Indiana, 46240
Clinical Research Associates Incorporated
Nashville, Tennessee, 37203
DMI Research
Pinellas Park, Florida, 33782-4533
About this study
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
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.
Read the 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.
- Conditions
- Common Cold, Infections, Upper Respiratory Tract
- Being tested
- Dextromethorphan, Placebo
- Keywords
- randomized, parallel, double-blind, placebo-controlled, cough, efficacy, safety, dextromethorphan
- Medical subject headings
- Common Cold, Respiratory Tract Infections, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DextromethorphanDrug
A single 10 mL dose of Children's Triaminic Syrup (Dextromethorphan Hydrobromide 7.5 mg per 5 mL (total dose of 15 mg)
PlaceboDrug
A single 10 mL dose of matching placebo syrup
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Not described Receives: Drug: Dextromethorphan |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Cough Count
Total cough count was done by trained assessors using continuous digital video and audio recordings.
Measured: Up to 6 hours post-dose
Secondary outcomes (6)
Change From Baseline in Perceived Verbal Cough Severity Scale for 6 Hour Post-Dose Period
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.
Measured: Baseline, 1, 2, 3, 4, 5, 6 hours post-dose
Change From Baseline in Verbal Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6
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.
Measured: Baseline, 1, 2, 3, 4, 5, 6 hours
Change From Baseline in Perceived Numerical Cough Severity Scale for 6 Hour Post-Dose Period
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.
Measured: Baseline, 1, 2, 3, 4, 5, 6 hour post-dose
Change From Baseline in Numerical Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6
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.
Measured: Baseline, 1, 2, 3, 4, 5, 6 hours
Participants' Global Assessment of Cough: Cough Severity
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.
Measured: Within 5 minutes after Hour 6
Participants' Global Assessment of Cough: Relief From Cough
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.
Measured: Within 5 minutes after Hour 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: See termination reason in detailed description.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Common ColdStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AccuDial Pharmaceutical, Inc., Boehringer Ingelheim, McNeil Consumer Healthcare Division of McNEIL-PPC, Inc., Novartis, Perrigo Company, Procter and Gamble, Reckitt Benckiser LLC
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257542
- Sponsor's protocol ID
- A6531001
- Other IDs
- RB-10-12
- Status last verified
- Aug 2012
- First submitted
- 7 Dec 2010
- Last updated
- 20 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01257542
- Acronym / sponsor ID
- A6531001
- Conditions
- Common Cold, Infections, Upper Respiratory Tract
- Keywords
- randomized, parallel, double-blind, placebo-controlled, cough, efficacy, safety, dextromethorphan
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 140 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- AccuDial Pharmaceutical, Inc., Boehringer Ingelheim, McNeil Consumer Healthcare Division of McNEIL-PPC, Inc., Novartis, Perrigo Company, Procter and Gamble, Reckitt Benckiser LLC
- Study start
- Dec 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 9 Dec 2010 (estimated)
- Results
- Posted 20 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: Dextromethorphan |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DextromethorphanA single 10 mL dose of Children's Triaminic Syrup (Dextromethorphan Hydrobromide 7.5 mg per 5 mL (total dose of 15 mg) | Drug | Active |
| PlaceboA single 10 mL dose of matching placebo syrup | Drug | Placebo |
Primary outcome
Total Cough Count
Time frame: Up to 6 hours post-dose
Total cough count was done by trained assessors using continuous digital video and audio recordings.
6 secondary outcomes
Change From Baseline in Perceived Verbal Cough Severity Scale for 6 Hour Post-Dose Period
Time frame: Baseline, 1, 2, 3, 4, 5, 6 hours post-dose
Change From Baseline in Verbal Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6
Time frame: Baseline, 1, 2, 3, 4, 5, 6 hours
Change From Baseline in Perceived Numerical Cough Severity Scale for 6 Hour Post-Dose Period
Time frame: Baseline, 1, 2, 3, 4, 5, 6 hour post-dose
Change From Baseline in Numerical Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6
Time frame: Baseline, 1, 2, 3, 4, 5, 6 hours
Participants' Global Assessment of Cough: Cough Severity
Time frame: Within 5 minutes after Hour 6
Participants' Global Assessment of Cough: Relief From Cough
Time frame: Within 5 minutes after Hour 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dextromethorphan in people with Common Cold and Infections, Upper Respiratory Tract, run by Pfizer at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Cough Count (time frame: Up to 6 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2012.