CoughPhase 4CHPA DXMNCT02651116
Dextromethorphan Pediatric Acute Cough Study
A Phase 4 study testing Dextromethorphan Hydrobromide and Cough recording device in people with Cough, run by Pfizer at 18 sites in United States.
Trial summary
This is a placebo-controlled, double-blind, randomized, parallel group pilot study in approximately 150 subjects to evaluate the efficacy of dextromethorphan hydrobromide (DXM) on acute cough in a pediatric population. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Cough
- What is being tested?
- Dextromethorphan Hydrobromide and Cough recording device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 131 participants
- Where
- 18 sitesUnited States
- Study dates
- 25 Feb 2016to 19 Mar 2020
- 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
- Generally healthy male or female children/adolescents ages 6 to 11 years, inclusive.
- Subject has an acute cough and other symptoms consistent with a common cold/acute upper respiratory tract infection (URTI) diagnosis as deemed by the investigator or qualified designee based on findings from medical history review, full physical examination and vital signs.
- The onset of symptoms must be no more than 3 days prior to Visit 1, as determined by the subject or parent/legally acceptable representative.
- Qualifying response on the Child Cold Symptom Checklist.
- Parent/legally acceptable representative, and subject agrees the subject will not use any other cough or cold treatments during the study.
Who cannot join
- A subchronic, or chronic cough due to any condition other than an URTI or common cold as established by the investigator, nurse practitioner, or physician's assistant, in accordance with the American College of Chest Physicians' (ACCP) Guidelines for Diagnosis and Management of Cough. Special attention should be paid to highly prevalent conditions commonly presenting with cough such as asthma, rhinitis, or gastroesophageal reflux disease (GERD).
- Symptoms of runny nose, stuffy nose, sore throat, or sneezing due to any condition other than URTI or common cold (eg, seasonal or perennial allergic rhinitis, sinusitis, strep throat, vasomotor rhinitis, etc.) as established by the investigator.
- An acute cough that occurs with excessive phlegm (mucus) or is chronic such as occurs with smoking, asthma, bronchitis, allergies, or a gastroesophageal condition (eg, acid reflux and GERD) or history of such a cough.
- Clinical features of a complication of the common cold during the physical examination at screening (eg, otitis media, sinusitis, or pneumonia) with or without the need for systematic antibiotics.
- Pneumonia (active or with a symptom-free period of <30 days), asthma (active or with a symptom-free period of <1 year), or other significant pulmonary diseases.
- Fever greater than 39ºC (102ºF oral temperature) at the time of screening if, in the judgment of the investigator, the individual is too ill to participate in the study or the fever is due to reasons other than URTI.
Show all 20Show fewer
- Signs of dehydration (as may be due to vomiting, diarrhea, or lack of fluid intake) during the physical examination at screening.
- Diabetes or hypoglycemic disorders.
- Known contraindications to the investigational product or acetaminophen (APAP).
- Sitting blood pressure reading at or above the limits as documented in the protocol.
- Obstructive sleep apnea caused by enlarged tonsils and adenoids, low muscle tone, or allergies.
- History of known or suspected allergy or hypersensitivity to dextromethorphan (DXM) or APAP, or any of the non medicinal ingredients contained in the single-blind confection, double-blind investigational products, or APAP.
- History of taking any of the specified prohibited medications or products within the corresponding washout periods prior to taking the first dose of investigational product.
- History of taking a medication that is sedating within the past 24 hours prior to screening (eg sedatives, hypnotics, tranquilizers, anticonvulsants, benzodiazepines, and clonidine).
- Subject has a sibling contemporaneously participating in this study.
- Randomization Criteria:
- Subjects must complete the 2 hour ambulatory cough counting baseline run-in recording period and must return to the study site for randomization at least 2 hours after the recording started.
- Subjects whose equipment failed, preventing collection of cough count data for at least 2 hours during the Baseline Run-in Period, or those who took off the device during this period will be excluded from further study participation.
- Subjects who do not return to the study site (before 3:30 pm) in time for the afternoon dose will not be randomized.
- Qualifying response on Child Global Question
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, 40004
Elite Clinical Trials LLLP
Blackfoot, Idaho, 83221
Coastal Pediatric Associates
Charleston, South Carolina, 29414
Rapid Medical Research, Inc
Cleveland, Ohio, 44122
Meridian Clinical Research, LLC
Dakota Dunes, South Dakota, 57049
Avail Clinical Research, LLC
DeLand, Florida, 32720
Texas Health Care, PLLC
Fort Worth, Texas, 76104
Ventavia Research Group, LLC
Fort Worth, Texas, 76104
Midwest Children's Health Research Institute
Lincoln, Nebraska, 68504
All Children Pediatrics
Louisville, Kentucky, 40243
Bluegrass Clinical Research, Inc
Louisville, Kentucky, 40291
Advanced Clinical Research
Meridian, Idaho, 83642
MedPharmics, LLC
Metairie, Louisiana, 70006
Coastal Pediatric Associates
Mt. Pleasant, South Carolina, 29464
Meridian Clinical Research LLC
Omaha, Nebraska, 68134
Carolina Ear, Nose & Throat Clinic/CENTRI Inc.
Orangeburg, South Carolina, 29118
Clinical Associates of Orlando LLC
Orlando, Florida, 32806
Advanced Clinical Research
West Jordan, Utah, 84088
About this study
Official title: A PLACEBO-CONTROLLED, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP PILOT STUDY TO EVALUATE THE EFFICACY OF DEXTROMETHORPHAN HYDROBROMIDE ON ACUTE COUGH IN A PEDIATRIC POPULATION
This is a placebo-controlled, double-blind, randomized, parallel group pilot study in approximately 150 subjects to evaluate the efficacy of dextromethorphan hydrobromide (DXM) on acute cough in a pediatric population. Subjects will be otherwise healthy males and females aged 6-11 inclusive who are experiencing acute cough as a symptom of common cold or upper respiratory tract infection. Subjects must have had onset of symptoms within 3 days of screening and qualify based on physical exam and symptom questionnaire. Eligible subjects will be given a single-blind placebo, and fitted with a cough counting device for a 2 hour run-in period. Qualifying subjects will be stratified by age and then randomized to either DXM or placebo in a 1:1 ratio and fitted with the cough recording device for the first 24 hours of treatment. Subjects will receive approximately 9 doses of investigational product over the course of the 4 day study and will complete patient reported outcome questions before the morning and afternoon doses. Subjects will return to the study site on Day 2 to remove the cough recorder and on Day 4 (+ 2 days) to complete the final visit. A review of any reported adverse events will also be completed.
Read the detailed description
This is a placebo-controlled, double-blind, randomized, parallel group pilot study in approximately 150 subjects to evaluate the efficacy of dextromethorphan hydrobromide DXM) on acute cough in a pediatric population. Subjects will be otherwise healthy males and females aged 6-11 inclusive who are experiencing acute cough as a symptom of common cold or upper respiratory tract infection. Subjects must have had onset of symptoms within 3 days of screening and qualify based on physical exam and symptom questionnaire. Eligible subjects will be given a single-blind placebo, and fitted with a cough counting device for a 2 hour run-in period. Qualifying subjects will be stratified by age and then randomized to either DXM or placebo in a 1:1 ratio and fitted with the cough recording device for the first 24 hours of treatment. Subjects will receive approximately 9 doses of investigational product over the course of the 4 day study and will complete patient reported outcome questions before the morning and afternoon doses. Subjects will return to the study site on Day 2 to remove the cough recorder and Day 4 (+2 days) to complete the final visit. A review of any reported adverse events will also be completed. Validated Patient Reported Outcomes (PRO) used in the study include morning cough assessment, afternoon cough assessment, Child Global Question, and Child Cold Symptom Checklist
- Conditions
- Cough
- Being tested
- Dextromethorphan Hydrobromide, Placebo, Cough recording device
- Keywords
- cough, acute cough, pediatric, Dextromethorphan Hydrobromide, antitussive, ambulatory cough recording device
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextromethorphan HydrobromideDrug
Also called DXM
15 mg/ 10 mL: 10 mL of Dextromethorphan Hydrobromide
PlaceboDrug
10 mL Placebo
Cough recording deviceDevice
Also called VitaloJAK
FDA approved device validated for use in adults and children
| Study group | Role | What they receive |
|---|---|---|
| Dextromethorphan Hydrobromide | Experimental | 15 mg/ 10 mL: 10 mL of Dextromethorphan Hydrobromide Receives: Drug: Dextromethorphan Hydrobromide; Device: Cough recording device |
| Placebo | Placebo comparator | 10 mL of Placebo Receives: Drug: Placebo; Device: Cough recording device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of Total Cough Counts: Over 24 Hours Post-First Dose on Day 1
Total cough count was collected by the cough recording device VitaloJAKTM in an ambulatory setting. The VitaloJAKTM device recorded continuous digital audio obtained through both a lapel microphone clipped to the participant's clothing at the neck or upper chest level, and a chest wall sensor attached to the participant's chest at the top of the sternum. Data was captured on a data card and the vitalograph analyst evaluated cough counts.
Measured: Over for 24 hours post-first dose on Day 1
Secondary outcomes (5)
Mean of Total Cough Counts: Between Dose 1 to Dose 2 on Day 1
Total cough count was collected by the cough recording device VitaloJAKTM in an ambulatory setting. The VitaloJAKTM device recorded continuous digital audio obtained through both a lapel microphone clipped to the participant's clothing at the neck or upper chest level, and a chest wall sensor attached to the participant's chest at the top of the sternum. Data was captured on a data card and the vitalograph analyst evaluated cough counts.
Measured: Between Dose 1 to Dose 2 on Day 1
Mean of Total Cough Counts: Between Dose 2 on Day 1 to Dose 3 on Day 2
Total cough count was collected by the cough recording device VitaloJAKTM in an ambulatory setting. The VitaloJAKTM device recorded continuous digital audio obtained through both a lapel microphone clipped to the participant's clothing at the neck or upper chest level, and a chest wall sensor attached to the participant's chest at the top of the sternum. Data was captured on a data card and the vitalograph analyst evaluated cough counts.
Measured: Between Dose 2 on Day 1 to Dose 3 on Day 2 (second dose of Day 1 to first dose of Day 2)
Mean of Total Cough Counts: Between Dose 3 to Dose 4 on Day 2
Total cough count was collected by the cough recording device VitaloJAKTM in an ambulatory setting. The VitaloJAKTM device recorded continuous digital audio obtained through both a lapel microphone clipped to the participant's clothing at the neck or upper chest level, and a chest wall sensor attached to the participant's chest at the top of the sternum. Data was captured on a data card and the vitalograph analyst evaluated cough counts.
Measured: Between Dose 3 to Dose 4 on Day 2 (between first and second dose of Day 2)
Mean of Total Cough Counts: Between Dose 1 to Dose 2 on Day 1, and Between Dose 3 to Dose 4 on Day 2
Total cough count was collected by the cough recording device VitaloJAKTM in an ambulatory setting. The VitaloJAKTM device recorded continuous digital audio obtained through both a lapel microphone clipped to the participant's clothing at the neck or upper chest level, and a chest wall sensor attached to the participant's chest at the top of the sternum. Data was captured on a data card and the vitalograph analyst evaluated cough counts. In this outcome measure, as planned combined data is reported for first dosing interval (Dose 1 to Dose 2) on Day 1 and first dosing interval (Dose 3 to Dose 4) on Day 2.
Measured: Duration between Dose 1 to Dose 2 on Day 1 (between first and second dose of Day 1) plus duration between Dose 3 to Dose 4 on Day 2 (between first and second dose of Day 2)
Mean of Total Cough Time Accumulated Over a 24-Hour Period Post-First Dose on Day 1
Time (in seconds) accumulated over a 24-hour period when cough events occurred was collected by the cough recording device VitaloJAKTM in an ambulatory setting. The VitaloJAKTM device recorded continuous digital audio obtained through both a lapel microphone clipped to the participant's clothing at the neck or upper chest level, and a chest wall sensor attached to the participant's chest at the top of the sternum. Data was captured on a data card and the vitalograph analyst evaluated total cough time accumulated.
Measured: Over for 24 hours post-first dose on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study start25 Feb 2016
- Primary completion19 Mar 2020
- Study completion19 Mar 2020
Why it stopped: The study was prematurely discontinued due to slow enrollment during the 2019/2020 cold season. No safety or efficacy concerns led to the decision to terminate
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 CoughStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02651116
- Sponsor's protocol ID
- A6531002
- Other IDs
- CHPA DXM
- Acronym
- CHPA DXM
- Status last verified
- Apr 2021
- First submitted
- 7 Jan 2016
- Last updated
- 28 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PLACEBO-CONTROLLED, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP PILOT STUDY TO EVALUATE THE EFFICACY OF DEXTROMETHORPHAN HYDROBROMIDE ON ACUTE COUGH IN A PEDIATRIC POPULATION
- ClinicalTrials.gov ID
- NCT02651116
- Acronym / sponsor ID
- CHPA DXM / A6531002
- Conditions
- Cough
- Keywords
- cough, acute cough, pediatric, Dextromethorphan Hydrobromide, antitussive, ambulatory cough recording device
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was prematurely discontinued due to slow enrollment during the 2019/2020 cold season. No safety or efficacy concerns led to the decision to terminate
- Enrolment
- 131 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2016 (actual)
- Primary completion
- 19 Mar 2020 (actual)
- Study completion
- 19 Mar 2020 (actual)
- First posted
- 8 Jan 2016 (estimated)
- Results
- Posted 28 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a placebo-controlled, double-blind, randomized, parallel group pilot study in approximately 150 subjects to evaluate the efficacy of dextromethorphan hydrobromide (DXM) on acute cough in a pediatric population. Subjects will be otherwise healthy males and females aged 6-11 inclusive who are experiencing acute cough as a symptom of common cold or upper respiratory tract infection. Subjects must have had onset of symptoms within 3 days of screening and qualify based on physical exam and symptom questionnaire. Eligible subjects will be given a single-blind placebo, and fitted with a cough counting device for a 2 hour run-in period. Qualifying subjects will be stratified by age and then randomized to either DXM or placebo in a 1:1 ratio and fitted with the cough recording device for the first 24 hours of treatment. Subjects will receive approximately 9 doses of investigational product over the course of the 4 day study and will complete patient reported outcome questions before the morning and afternoon doses. Subjects will return to the study site on Day 2 to remove the cough recorder and on Day 4 (+ 2 days) to complete the final visit. A review of any reported adverse events will also be completed.
Detailed description
This is a placebo-controlled, double-blind, randomized, parallel group pilot study in approximately 150 subjects to evaluate the efficacy of dextromethorphan hydrobromide DXM) on acute cough in a pediatric population. Subjects will be otherwise healthy males and females aged 6-11 inclusive who are experiencing acute cough as a symptom of common cold or upper respiratory tract infection. Subjects must have had onset of symptoms within 3 days of screening and qualify based on physical exam and symptom questionnaire. Eligible subjects will be given a single-blind placebo, and fitted with a cough counting device for a 2 hour run-in period. Qualifying subjects will be stratified by age and then randomized to either DXM or placebo in a 1:1 ratio and fitted with the cough recording device for the first 24 hours of treatment. Subjects will receive approximately 9 doses of investigational product over the course of the 4 day study and will complete patient reported outcome questions before the morning and afternoon doses. Subjects will return to the study site on Day 2 to remove the cough recorder and Day 4 (+2 days) to complete the final visit. A review of any reported adverse events will also be completed. Validated Patient Reported Outcomes (PRO) used in the study include morning cough assessment, afternoon cough assessment, Child Global Question, and Child Cold Symptom Checklist
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dextromethorphan Hydrobromide | Experimental | Drug: Dextromethorphan Hydrobromide, Device: Cough recording device15 mg/ 10 mL: 10 mL of Dextromethorphan Hydrobromide |
| Placebo | Placebo comparator | Drug: Placebo, Device: Cough recording device10 mL of Placebo |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Generally healthy male or female children/adolescents ages 6 to 11 years, inclusive.
- Subject has an acute cough and other symptoms consistent with a common cold/acute upper respiratory tract infection (URTI) diagnosis as deemed by the investigator or qualified designee based on findings from medical history review, full physical examination and vital signs.
- The onset of symptoms must be no more than 3 days prior to Visit 1, as determined by the subject or parent/legally acceptable representative.
- Qualifying response on the Child Cold Symptom Checklist.
- Parent/legally acceptable representative, and subject agrees the subject will not use any other cough or cold treatments during the study.
Key exclusion criteria (20 listed)
- A subchronic, or chronic cough due to any condition other than an URTI or common cold as established by the investigator, nurse practitioner, or physician's assistant, in accordance with the American College of Chest Physicians' (ACCP) Guidelines for Diagnosis and Management of Cough. Special attention should be paid to highly prevalent conditions commonly presenting with cough such as asthma, rhinitis, or gastroesophageal reflux disease (GERD).
- Symptoms of runny nose, stuffy nose, sore throat, or sneezing due to any condition other than URTI or common cold (eg, seasonal or perennial allergic rhinitis, sinusitis, strep throat, vasomotor rhinitis, etc.) as established by the investigator.
- An acute cough that occurs with excessive phlegm (mucus) or is chronic such as occurs with smoking, asthma, bronchitis, allergies, or a gastroesophageal condition (eg, acid reflux and GERD) or history of such a cough.
- Clinical features of a complication of the common cold during the physical examination at screening (eg, otitis media, sinusitis, or pneumonia) with or without the need for systematic antibiotics.
- Pneumonia (active or with a symptom-free period of <30 days), asthma (active or with a symptom-free period of <1 year), or other significant pulmonary diseases.
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 |
|---|---|---|
| Dextromethorphan HydrobromideAlso: DXM15 mg/ 10 mL: 10 mL of Dextromethorphan Hydrobromide | Drug | Dextromethorphan Hydrobromide |
| Placebo10 mL Placebo | Drug | Placebo |
| Cough recording deviceAlso: VitaloJAKFDA approved device validated for use in adults and children | Device | Dextromethorphan Hydrobromide, Placebo |
Primary outcome
Mean of Total Cough Counts: Over 24 Hours Post-First Dose on Day 1
Time frame: Over for 24 hours post-first dose on Day 1
Total cough count was collected by the cough recording device VitaloJAKTM in an ambulatory setting. The VitaloJAKTM device recorded continuous digital audio obtained through both a lapel microphone clipped to the participant's clothing at the neck or upper chest level, and a chest wall sensor attached to the participant's chest at the top of the sternum. Data was captured on a data card and the vitalograph analyst evaluated cough counts.
5 secondary outcomes
Mean of Total Cough Counts: Between Dose 1 to Dose 2 on Day 1
Time frame: Between Dose 1 to Dose 2 on Day 1
Mean of Total Cough Counts: Between Dose 2 on Day 1 to Dose 3 on Day 2
Time frame: Between Dose 2 on Day 1 to Dose 3 on Day 2 (second dose of Day 1 to first dose of Day 2)
Mean of Total Cough Counts: Between Dose 3 to Dose 4 on Day 2
Time frame: Between Dose 3 to Dose 4 on Day 2 (between first and second dose of Day 2)
Mean of Total Cough Counts: Between Dose 1 to Dose 2 on Day 1, and Between Dose 3 to Dose 4 on Day 2
Time frame: Duration between Dose 1 to Dose 2 on Day 1 (between first and second dose of Day 1) plus duration between Dose 3 to Dose 4 on Day 2 (between first and second dose of Day 2)
Mean of Total Cough Time Accumulated Over a 24-Hour Period Post-First Dose on Day 1
Time frame: Over for 24 hours post-first dose on Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- 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.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Related trials for Cough
RecruitingPhase 4
Remifentanil Versus Remifentanil-Lidocaine for Tracheal Extubation After Thyroidectomy
Tracheal Extubation, Cough
RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
Not yet recruitingObservational study
Assessment of the Acceptability of, and Factors Associated With, Recommended Vaccinations During Pregnancy in Maternity Units in the Ile-de-France Region
Vaccination Coverage Among Pregnant Women
Not yet recruitingPhase 4
A 2x2 Factorial, Randomized, Open-label Trial to Evaluate Neuromodulators and Cough Control Therapy in Patients With Refractory or Unexplained Chronic Cough
Cough, Refractory Chronic Cough
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
18 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 Hydrobromide and Cough recording device in people with Cough, run by Pfizer at 18 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 5 inclusion and 20 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 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 28 Apr 2021). 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?
Mean of Total Cough Counts: Over 24 Hours Post-First Dose on Day 1 (time frame: Over for 24 hours post-first dose on Day 1). 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 28 Apr 2021; AzTrials last refreshed its copy on 29 Oct 2026.