Dextromethorphan Pediatric Acute Cough 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.

Timeline

Start

2016-02-25

Primary completion

2020-03-19

Completion

2020-03-19

Outcome

Met primary endpoint

Stopped (Enrollment): “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”

registry analysis (superiority test); Dextromethorphan Hydrobromide vs Placebo; p = 0.0449; Rate Ratio 0.7899 (95% CI 0.6273 to 0.9947); Negative Binomial Regression NCT02651116 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dextromethorphan	Unknown	15 mg	—

Indications

No indication recorded.