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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: Clinical Trial Phase 4 study, sponsored by Pfizer.
NCT02651116 is a Phase 4 study that was terminated before completion, run by Pfizer. The registered enrollment target is 131 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
Why NCT02651116 stopped before completion
NCT02651116 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02651116 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT02651116's enrollment target sits among peer trials
131 619th of 2000 higher than 1,379 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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