In short
Clinical trials are studying 2,4 DICHLOROBENZYL ALCOHOL in lozenges for people with acute pharyngitis, which means a sudden sore throat. These trials look at whether the treatment helps relieve symptoms and how safe it is. The studies compare it with placebo and an active comparator in adults with acute pharyngitis.
Key points
- Clinical trials are studying 2,4 DICHLOROBENZYL ALCOHOL in lozenges for acute pharyngitis, a sudden sore throat condition. Both trials are Phase 3 and use a randomised, double-blind, placebo-controlled design. They compare the study treatment with placebo and with an active comparator. The target population is patients with acute pharyngitis. The main result being measured is change in throat soreness during the first 2 hours after treatment.
Trials overview
Two interventional trials are studying 2,4 DICHLOROBENZYL ALCOHOL in lozenges for people with acute pharyngitis, which means a sudden sore throat.12
Both studies are designed to check whether the lozenges help with symptoms and whether they are safe in this setting.12
Study design and groups
Each trial is a Phase 3, prospective, randomised, multi-centre, double-blind, placebo-controlled study.12
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.12
The studies compare the test lozenges with a placebo and with an active comparator, which is another treatment used as a reference.12
The brief summary says the goal is to test non-inferiority against the active comparator and superiority against placebo.12
Who can participate
The target population is patients with acute pharyngitis.12
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.12
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 0.12
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.12
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.12
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One trial is withdrawn, which means it did not continue as planned.1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.12
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.12
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.12
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.12