Dextromethorphan Pediatric Acute Cough Study
Public ClinicalTrials.gov record NCT02651116. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02651116
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 131 participants
Conditions and interventions
Conditions
Interventions
- Dextromethorphan Hydrobromide Drug
- Placebo Drug
- Cough recording device Device
Drug · Device
Eligibility (public fields only)
- Age range
- 6 Years to 11 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 24, 2016
- Primary completion
- Mar 18, 2020
- Completion
- Mar 18, 2020
- Last update posted
- Apr 27, 2021
2016 – 2020
United States locations
- U.S. sites
- 18
- U.S. states
- 10
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Avail Clinical Research, LLC | DeLand | Florida | 32720 | — |
| Clinical Associates of Orlando LLC | Orlando | Florida | 32806 | — |
| Elite Clinical Trials LLLP | Blackfoot | Idaho | 83221 | — |
| Advanced Clinical Research | Meridian | Idaho | 83642 | — |
| Kentucky Pediatric/Adult Research | Bardstown | Kentucky | 40004 | — |
| All Children Pediatrics | Louisville | Kentucky | 40243 | — |
| Bluegrass Clinical Research, Inc | Louisville | Kentucky | 40291 | — |
| MedPharmics, LLC | Metairie | Louisiana | 70006 | — |
| Midwest Children's Health Research Institute | Lincoln | Nebraska | 68504 | — |
| Meridian Clinical Research LLC | Omaha | Nebraska | 68134 | — |
| Rapid Medical Research, Inc | Cleveland | Ohio | 44122 | — |
| Coastal Pediatric Associates | Charleston | South Carolina | 29414 | — |
| Coastal Pediatric Associates | Mt. Pleasant | South Carolina | 29464 | — |
| Carolina Ear, Nose & Throat Clinic/CENTRI Inc. | Orangeburg | South Carolina | 29118 | — |
| Meridian Clinical Research, LLC | Dakota Dunes | South Dakota | 57049 | — |
| Texas Health Care, PLLC | Fort Worth | Texas | 76104 | — |
| Ventavia Research Group, LLC | Fort Worth | Texas | 76104 | — |
| Advanced Clinical Research | West Jordan | Utah | 84088 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02651116, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 27, 2021 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02651116 live on ClinicalTrials.gov.