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

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

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Site Name City Country Status
Azienda Sociosanitaria 3 Genoa Italy

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Trial status

Country Status Recruitment Start
Italy Italy
Not yet recruiting
01.04.2026

Trial locations

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.

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 ID:
2025-521526-15-00
Protocol code:
030(Z)MD24076
Trial Phase:
Therapeutic confirmatory (Phase III)

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