Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruiting

Benzydamine Hydrochloride Lozenges for Non-Streptococcal Pharyngotonsillitis in Children Aged 6 to 11 Years

Registered drugNo placebo
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 clinical study is being done in children with non-streptococcal pharyngotonsillitis, which is a sore throat and swollen throat and tonsils that is not caused by streptococcal bacteria. The treatment used is benzydamine hydrochloride lozenges, sold as Tantum Verde 3 mg mint-flavored lozenges. The purpose of the study is to see whether these lozenges help reduce throat pain.

In this study, the children take the lozenge and are followed for a short time after the first dose, with pain checked over the first hour and then again later over the next few days. The study looks at how the pain changes after the lozenge is placed in the mouth and how quickly the pain gets better or goes away. It also records whether any other pain medicine, such as paracetamol, or antibiotics are needed, and monitors safety during the study.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study treatment begins

    After joining the study, you take the test medicine called Tantum Verde P 3 mg mint lozenges, which contain benzydamine hydrochloride.

    The lozenge is used by mouth and is placed in the mouth to dissolve.

    The study follows the effect of this medicine on throat pain in children aged 6 to 11 years with non-streptococcal pharyngotonsillitis, which means throat and tonsil inflammation not caused by streptococcal bacteria.

  2. Step 2

    First 60 minutes after the first lozenge

    During the first 60 minutes after the first lozenge is placed in your mouth, your throat pain is checked at 5, 10, 15, 20, 25, 30, and 60 minutes.

    Pain is measured using WBFPRS, which means a word-based facial pain scale. This is a pain scale that uses faces and simple words to show how much pain you feel.

    At the same time, images of your throat area are taken to see whether the warm area in the throat changes after treatment. The study compares these images with the pain scores during this first hour.

  3. Step 3

    Pain relief and throat image changes are checked over time

    The study checks how long it takes after the first lozenge for you to have the first meaningful pain reduction, which means a decrease of at least 2 points on the WBFPRS pain scale.

    The study also checks how long it takes for the throat images to show a first defined improvement, which means at least a 15% reduction in the warm area seen on the images.

  4. Step 4

    Continued checks at later time points

    Your pain is also checked at 24, 48, and 72 hours after treatment begins.

    At each of these time points, the study notes the number of children who have a meaningful pain reduction and the change in pain score from the start of the study.

  5. Step 5

    Pain disappearance and lozenge use

    The study records the time when your pain becomes 0 on the WBFPRS scale, which means complete pain disappearance.

    The number of lozenges taken before pain fully disappears is also recorded.

  6. Step 6

    Other treatments and safety checks during the study

    The study records whether you need paracetamol or antibiotics during the study.

    Safety is checked by looking for adverse events, which means any unwanted medical problems that happen during the study.

    Your vital signs are checked. Vital signs are basic body measurements such as pulse and blood pressure.

    Your oral temperature is measured, and a physical examination is performed.

    The study also records if the study medicine is stopped early and the reason for stopping it.

Who can join the trial?

9 criteria

  • A written informed consent must be signed and dated. This means the parents or legal guardian must agree in writing to the child taking part and to the use of the child’s data. The child must also sign an assent form, which is a simpler agreement form written for children, if the investigator decides it is appropriate for the child’s age. If one parent cannot sign because they are absent, far away, or have another serious reason, the parent who is present must write a statement saying why the other parent could not sign.
  • The patient must be a boy or girl between 6 and 11 years old, including both 6 and 11 years.
  • Girls must be before their first menstrual period at the time the consent and assent forms are signed. The menstrual period is the monthly bleeding that starts puberty. If this changes during the 3 days of the study, the parents or guardian must tell the investigator right away.
  • The sore throat must have started within the last 36 hours.
  • The child must have pharyngotonsillitis confirmed by a TPA score of 5 or higher. The TPA scale is a doctor’s scoring system used to check signs in the throat and tonsils.
  • The child must have at least 2 points on the WBFPRS, which means at least 1 face on this pain scale. The WBFPRS is a pain scale that uses faces to show how much pain the child has.
  • The child’s oral body temperature must be 38.0°C or lower. Oral body temperature means temperature taken by mouth.
  • The child must not have used benzydamine hydrochloride in any form, such as a spray or lozenge, in the 24 hours before joining the study. Benzydamine hydrochloride is a medicine used for throat pain and swelling.
  • The child must have a negative test for group A beta-hemolytic Streptococcus, also called S. pyogenes. This means the throat infection is not caused by this type of bacteria.

Who cannot join the trial?

14 criteria

  • Known allergy or sensitivity to benzydamine hydrochloride or any of the other ingredients in the study medicine. “Hypersensitivity” means the body reacts badly to a medicine.
  • Use of any inhaled treatment in the week before the first study medicine dose. An inhaled treatment is a medicine breathed into the lungs, such as through an inhaler or nebulizer.
  • Use of any anti-inflammatory medicine, fever-reducing medicine, steroids, local anesthetics (medicine that numbs an area), antiseptics (germs-killing medicines), decongestants, antihistamines, expectorants (medicines that help loosen mucus), cough suppressants, antibiotics, or natural/herbal products such as herbal infusions or propolis, within 48 hours before joining the study.
  • Participation in another clinical trial within the past 3 months.
  • A parent or legal guardian who cannot fully understand the study or follow the study requirements.
  • Any other illness that can also cause sore throat, such as gastroesophageal reflux (stomach acid coming back up into the throat), exposure to toxic substances, or an allergic reaction.
  • Known or suspected phenylketonuria, a condition in which the body cannot properly handle a substance called phenylalanine.
  • Known or suspected fructose intolerance, a condition in which the body cannot properly digest fructose, a type of sugar.
  • Abnormal findings on the physical examination that the study doctor considers important.
  • Intolerance to acetylsalicylic acid or other NSAIDs (non-steroidal anti-inflammatory drugs, a common type of pain and swelling medicine).
  • History of asthma or a diagnosis of asthma.
  • Any illness that makes breathing difficult, such as bronchopneumonia (an infection of the lungs and small airways).
  • Severe coughing that causes throat discomfort, if judged by the study doctor.
  • Purulent plaques on the tonsils, meaning white or yellow pus-like spots on the tonsils.
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

Trial locations

Where you can join this trial

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

Not yet 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

Tantum Verde is a medicine in lozenge form that is dissolved slowly in the mouth. It contains benzydamine hydrochloride, which is used to help relieve pain and discomfort in the throat and tonsils. In this study, it is being tested to see how well it reduces throat pain in children with non-streptococcal pharyngotonsillitis after the first lozenge is placed in the mouth.

What is already known about the treatment

Benzydamine hydrochloride - This medicine is given as a lozenge that is placed in the mouth and allowed to dissolve slowly, so it acts directly on the throat and mouth lining. It is an established medicine in clinical use and medical literature, mainly used to relieve pain, swelling, and irritation in the mouth and throat, including sore throat and inflamed tonsils. It belongs to the group of local pain-relieving and anti-inflammatory medicines, and it works by calming the body’s inflammatory signals at the site of use, helping reduce swelling and discomfort.

Investigated diseases

Nonstreptococcal pharyngotonsillitis - This is inflammation of the pharynx and tonsils that is not caused by streptococcal bacteria. It usually begins with a sore throat, throat redness, and pain when swallowing, and the discomfort may spread to the surrounding throat tissues. The condition can develop with swelling and irritation of the throat lining, making the throat feel dry, raw, or tender. Symptoms may change over time as the inflammation lessens, but the throat can remain sore for several days.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2025-521526-15-00Protocol code030(Z)MD24076Estimated enrolment120 patientsSponsorAngelini Pharma Italia Aziende Chimiche Riunite Angelini Francesc O A.C.R.A.F. S.p.A.

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.