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Clinical Trials in the EU / 2025-521764-35-00
Authorised Phase III

A prospective, multi-centre, randomised, double-blind, placebo-controlled Phase III trial to investigate the efficacy and safety of lozenges with benzydamine hydrochloride and dichlorobenzyl alcohol in the symptomatic treatment of patients suffering from acute pharyngitis

2025-521764-35-00 · tracked via the Priya Life Science EU tracker
Sponsor
MEDICE Arzneimittel Puetter GmbH & Co. KG
Sponsor type
Pharmaceutical company
Therapeutic area
Otorhinolaryngologic Diseases
Decision date
19/09/2025
Enrollment target
810
Sites
Germany

Condition studied

acute pharyngitis

Investigational medicinal product(s)

DoriDuoMebocaína Anti-Inflam1.2 mg + 3 mgcomprimidos para chuparPlacebo to Test and Comparator

Eligibility

Age group
65+ years, 18-64 years
Sex
Female, Male

Primary endpoint

Superiority of IMP 1 in comparison to IMP 3 (Placebo) and for non-inferiority of IMP 1 in comparison to IMP 2 (reference) and is defined as area Under Curve (AUC) of changes from Baseline in Throat Soreness Intensity Scale (TSS) over the time course of 2 hours after first application on Day 0

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-521764-35-00 on CTIS ↗ ← All trials in the EU