PHASE IV, PROSPECTIVE, OPEN-LABEL, SINGLE ARM STUDY ON THE PAIN-RELIEF EFFECT OF BENZYDAMINE HYDROCHLORIDE LOZENGES 3 MG MINT TASTE (TANTUM VERDE) IN NON STREPTOCOCCAL PHARYNGOTONSILLITIS IN PEDIATRIC AGE (6-11 YEARS OLD).
This study, called a 'Phase IV' trial, is looking at how a specific type of lozenge, Tantum Verde 3mg with a mint flavour, helps children aged 6 to 11 who have a sore throat (pharyngotonsillitis) that isn't caused by strep bacteria. The main aim is to see how quickly and how much the lozenge reduces their pain and inflammation within the first hour of using it. Researchers will measure this by looking at changes in throat temperature using special heat-sensing pictures and by asking children about their pain using a special pain scale. They will also track how long it takes for a child's pain to significantly improve or disappear, how many lozenges are used, and whether other medicines like paracetamol or antibiotics are needed. The study also monitors for any side effects.
At a glance
What is this study about?
This study is looking into how well a medicine called Tantum Verde, in a 3mg mint-flavoured lozenge, helps children between 6 and 11 years old who have a sore throat. This particular type of sore throat isn't caused by a common germ called 'strep'. Because it's a 'Phase IV' study, it means the medicine is already approved and available, and researchers are now gathering more information on how it works in real-world use, particularly focusing on how well it eases pain in children.
The main goal of the study is to understand how quickly the lozenges start working to reduce pain and inflammation in the throat. Researchers will use special infrared cameras to take pictures of the throat, which helps them see changes in warmth or inflammation. They will also ask children to rate their pain using a special picture scale to see how much it improves within the first hour of taking a lozenge.
Beyond the first hour, the study will also look at other important things. This includes how long it takes for pain to noticeably decrease or completely go away, how many lozenges a child needs, and whether they still need other pain relievers or antibiotics during the study. They will also carefully check for any unwanted effects or side effects, making sure the lozenges are safe for children to use.
Key takeaways
- This study is testing Tantum Verde lozenges for children's sore throats.
- It's for children aged 6 to 11 with non-strep sore throats.
- Researchers will track how quickly pain is reduced.
- They also monitor for safety and how many lozenges are used.
- The study lasts up to 72 hours for each child.
Who may be eligible?
Children between 6 and 11 years old are invited to take part in this study. They need to have a sore throat (pharyngotonsillitis) that is not caused by a specific bacterial infection, such as 'strep throat'.
Both boys and girls can take part. There may be other specific health checks or conditions that mean a child can or cannot join the study, but these will be discussed in detail by the study team.
Ultimately, a doctor involved in the study will confirm if your child is suitable to participate.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Is my child between 6 and 11 years old?
- Does my child have a sore throat that a doctor says isn't 'strep throat'?
- Am I comfortable with my child using a mint-flavoured lozenge?
- Can my child understand and use a simple pain scale?
- Am I able to ensure my child attends required appointments or check-ins?
What does participation involve?
If your child takes part, they will be given the mint-flavoured Tantum Verde 3mg lozenges. The study will mainly focus on the first 60 minutes after the first lozenge is used. During this time, they will have their throat checked several times, likely using a special heat-sensing camera for pictures, and they will be asked to describe their pain using a simple scale (called a WBFPRS).
After the first hour, assessments will continue at various points, including 24, 48, and 72 hours later, to see how the pain changes over time. You'll also be asked to keep track of how many lozenges your child uses and if they need any other medicine for pain. Throughout the study, the team will check your child's general health, including vital signs and looking for any side effects. The total duration of the study's active observation period for your child will be for up to 72 hours.
Potential risks and benefits
Locations (1)
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Common questions
What kind of sore throat is this study for?
This study is for sore throats that aren't caused by a common bacterial infection called 'strep throat'. It's for general sore throats in children.
How old do children need to be to join?
Children aged between 6 and 11 years old can take part in this study.
What is 'Tantum Verde'?
Tantum Verde is the name of the mint-flavoured lozenge (a type of cough sweet) being tested in this study for its pain-relieving effects.
Will my child have to visit the clinic many times?
There will be several checks during the first hour after taking the lozenge, and ongoing assessments for up to 72 hours. The study team will explain the exact schedule of visits or check-ins.
What happens if the lozenge doesn't help my child's pain?
The study team will be monitoring your child's pain closely. If the lozenge isn't helping, or if their condition worsens, they will discuss alternative treatments and support with you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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