Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Testing benzydamine hydrochloride and dichlorobenzyl alcohol lozenges for relief of sore throat symptoms in patients with acute pharyngitis

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study examines acute pharyngitis, which is an inflammation of the throat that causes soreness and discomfort. The study will test lozenges containing two active substances: benzydamine hydrochloride and 2,4 dichlorobenzyl alcohol. These substances work together to reduce inflammation and provide local numbing effects in the throat. The study will compare these lozenges with another product already available on the market and with placebo. The purpose of this study is to determine how well the lozenges work in relieving symptoms of acute pharyngitis and to assess their safety.

Participants in this study will be adults who have recently developed acute pharyngitis with significant throat soreness that started within the last 30 hours. The study is designed so that neither the participants nor the researchers know which treatment is being given during the trial. Each person will receive lozenges to dissolve slowly in the mouth. The treatment will last for up to 4 days, during which participants will need to use an electronic device such as a smartphone or tablet to record information about their symptoms.

The main focus of the study is to measure how much the throat soreness improves during the first 2 hours after taking the first lozenge. Researchers will track changes in throat pain intensity by comparing the new lozenges with both placebo and the existing market product. All three types of lozenges are taken in the same way, by placing them in the mouth and allowing them to dissolve slowly. The maximum daily dose is 25.2 milligrams, and the total amount used over the treatment period will not exceed 84 milligrams.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and treatment start

    On the first day, referred to as Day 0, your throat pain intensity will be measured using a throat soreness scale. This scale helps assess how severe your throat pain is at the beginning.

    You will receive one of three types of lozenges to dissolve slowly in your mouth. The lozenges are for oropharyngeal use, which means they are designed to treat the throat and mouth area.

    The lozenges may contain benzydamine hydrochloride and dichlorobenzyl alcohol as active ingredients, or they may be a placebo with no active medication. A placebo is an inactive treatment used for comparison purposes.

    You will take the first lozenge and your throat pain will be monitored over the following 2 hours to assess how the treatment affects your symptoms.

  2. Step 2

    Continued treatment period

    You will continue taking the lozenges as directed throughout the treatment period.

    The lozenges are designed to provide relief from symptoms of acute pharyngitis, which is an inflammation of the throat causing pain and discomfort.

    You will need to use an internet-enabled electronic device such as a mobile phone, smartphone, tablet, or computer throughout the entire duration of the trial to record information about your symptoms and treatment.

  3. Step 3

    Monitoring and assessment

    Your throat pain and other symptoms will be regularly assessed during the trial.

    Changes in your throat soreness intensity from the initial assessment will be recorded and compared over time.

    The trial will monitor both the effectiveness of the treatment in reducing your symptoms and any side effects you may experience.

Who can join the trial?

6 criteria

  • You must be 18 years of age or older
  • You must sign an informed consent, which is a document showing you agree to take part in the study after understanding what it involves
  • You must have acute pharyngitis, which is a sudden inflammation of the throat, diagnosed by a doctor with a specific score of at least 5 points on a medical scale
  • Your symptoms must have started recently, no more than 30 hours ago
  • You must have significant throat soreness with a score of at least 7 points on a throat pain scale
  • You must have your own internet-connected electronic device such as a mobile phone, smartphone, tablet, or computer that you can use throughout the entire study

Who cannot join the trial?

3 criteria

  • The source data does not provide specific exclusion criteria for this clinical trial
  • This means there is no detailed information available about which patients cannot participate in this study
  • Typically, exclusion criteria would list medical conditions, medications, or other factors that would prevent someone from joining a trial, but these details are not included in the provided information
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Benzydamine hydrochloride and dichlorobenzyl alcohol lozenges

    are throat lozenges that combine two active ingredients to help relieve symptoms of sore throat. Benzydamine hydrochloride works to reduce pain and inflammation in the throat, while dichlorobenzyl alcohol has antiseptic properties that help fight germs. These lozenges are dissolved slowly in the mouth to provide relief for patients with acute pharyngitis, which is a medical term for a sore and inflamed throat.

  • Active comparator

    is another medication used to treat sore throat that is already known to work. In this trial, it is being used to compare how well the benzydamine hydrochloride and dichlorobenzyl alcohol lozenges work against an established treatment option.

What is already known about the treatment

Benzydamine Hydrochloride and Dichlorobenzyl Alcohol Lozenges – This medication is administered as lozenges that dissolve slowly in the mouth and is currently being studied in clinical trials for treating throat pain and inflammation. It is intended for patients with acute pharyngitis, which is a sudden inflammation of the throat that causes soreness and difficulty swallowing. The combination contains benzydamine hydrochloride, which works by blocking chemicals in the body that cause pain and swelling, and dichlorobenzyl alcohol, which acts as an antiseptic to help kill bacteria and germs in the throat. This medication belongs to the class of local anti-inflammatory and antiseptic agents used for oral and throat conditions.

Investigated diseases

Acute Pharyngitis – Acute pharyngitis is an inflammation of the throat that develops suddenly and causes pain when swallowing. The condition typically begins with a scratchy or sore feeling in the throat that may worsen over the first few days. It is commonly caused by viral or bacterial infections that affect the pharynx, which is the area at the back of the throat. Patients often experience throat discomfort, redness, and swelling of the throat tissues. The symptoms usually include throat soreness, difficulty swallowing, and sometimes fever or swollen lymph nodes in the neck. The condition generally develops rapidly and can make eating, drinking, and speaking uncomfortable.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521764-35-01Protocol code6630-9450-01Estimated enrolment810 patientsSponsorMEDICE Arzneimittel Puetter GmbH & Co. KG

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.