Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02651116 · ClinicalTrials.gov registry record · Phase 4
Dextromethorphan Pediatric Acute Cough Study
A Phase 4 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 4
- Development phase
- 131
- Enrollment target
NCT02651116 is a Phase 4 study that was terminated before completion, run by Pfizer. The registered enrollment target is 131 participants.
The verdict
NCT02651116, a Phase 4 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 131 participants
- Enrollment target
Study 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. 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.
Interventions
- DRUG Placebo
- DRUG Dextromethorphan Hydrobromide
- DEVICE Cough recording device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2016-02-25 |
| Est. Completion | 2020-03-19 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02651116
The ClinicalTrials.gov registry entry for NCT02651116 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02651116 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02651116 about?
NCT02651116 is a clinical study titled "Dextromethorphan Pediatric Acute Cough Study". 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 ...
What is the current status of trial NCT02651116?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 131 participants. The study started on 2016-02-25. Estimated completion is 2020-03-19.
What interventions are being tested in trial NCT02651116?
The interventions under investigation include: Placebo (DRUG), Dextromethorphan Hydrobromide (DRUG), Cough recording device (DEVICE).
Who is sponsoring clinical trial NCT02651116?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.