Table of Contents
- Trials overview
- Study design and groups
- Who can participate
- What the trials measure
- Trial status and size
- What this means for patients
Trials overview
Two interventional trials are studying 2,4 DICHLOROBENZYL ALCOHOL in lozenges for people with acute pharyngitis, which means a sudden sore throat.[1][2]
Both studies are designed to check whether the lozenges help with symptoms and whether they are safe in this setting.[1][2]
Study design and groups
Each trial is a Phase 3, prospective, randomised, multi-centre, double-blind, placebo-controlled study.[1][2]
Randomised means people are assigned to groups by chance, and double-blind means neither the patient nor the study team knows which treatment is being given during the trial.[1][2]
The studies compare the test lozenges with a placebo and with an active comparator, which is another treatment used as a reference.[1][2]
The brief summary says the goal is to test non-inferiority against the active comparator and superiority against placebo.[1][2]
Who can participate
The target population is patients with acute pharyngitis.[1][2]
The source data do not list age limits, sex limits, or other detailed entry rules, so the main known requirement is having the condition being studied.[1][2]
What the trials measure
The primary outcome is the change in Throat Soreness Intensity Scale (TSS) from baseline over the first 2 hours after the first application on Day 0.[1][2]
The trials use area under the curve (AUC), which is a way to add up symptom changes over time and show the total effect during the 2-hour period.[1][2]
In simple terms, the study is asking whether the lozenges reduce throat soreness better than placebo and whether they perform as well as the reference treatment.[1][2]
Trial status and size
One trial is withdrawn, which means it did not continue as planned.[1]
The other trial is authorised, which means it was allowed to proceed.[2]
Each study planned to enroll 810 participants, so the combined planned enrollment was large for a symptom-relief study in acute pharyngitis.[1][2]
What this means for patients
These trials focus on short-term relief of sore throat symptoms, not on long-term treatment of a chronic disease.[1][2]
Because the studies are Phase 3 and compare the treatment with placebo and another active lozenge, they are meant to give stronger evidence about how well the product works in real patients with acute pharyngitis.[1][2]
The available data are focused on symptom relief, study design, and trial status, and do not provide more detailed patient selection rules or extra outcome measures.[1][2]
