The Performance and Safety of Petit Drill in the French Paediatric Population: a Post-market Clinical Follow-up Study.

Launched by PIERRE FABRE MEDICAMENT · Nov 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a syrup called Petit Drill, which is designed to help soothe sore throats and dry coughs in young children, specifically those aged 6 months to 6 years. The trial aims to see how effective this syrup is in real-life situations for children experiencing throat irritation. It’s important to note that the use of Petit Drill is supported by health organizations and is considered a good option for managing these symptoms in young kids.

To participate in the trial, children must be between 6 months and 6 years old and have a cough lasting less than 48 hours, along with some throat discomfort. Parents or guardians will need to purchase the syrup from a participating pharmacy and provide consent for their child to join. Participants will be asked to use the syrup for three days and complete some questionnaires via a smartphone app to help the researchers gather information about its effectiveness. This study is currently recruiting, and it’s a great opportunity for families to contribute to understanding how this product may help children with cough and sore throat symptoms.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Boys or girls, 6 months to 6 years of age;
• • With one of his/her parents/legal guardian purchases Petit Drill in a participating pharmacy in accordance with recommendations for use (regarding age and type of cough);
• • For infants between 6 months and 12 months of age - a confirmed prescription from a treating physician;
• • With an acute cough lasting less than 48 hours
• • With a score ≥ 3 at least for 3 of the 5 items of PCQ, (based on assessment of the night before inclusion);
• • For whom child-minding will allow to respect the recommended daily doses of Petit Drill during the 3 day-treatment;
• • With a parent/legal guardian having a smartphone allowing using the ePRO App. NursTrial®;
• • With a parent/legal guardian able to understand and to complete to the questionnaires in timely manner;
• • With parent(s)/legal guardian who provide their signed informed consent for the child's enrolment in the study.
• Exclusion Criteria:
• • Presenting with one of the following conditions: Chronic respiratory illness such as asthma, recurrent wheezing associated to viral infections and bronchitis or lower respiratory infections, such as bronchitis, bronchiolitis, and pneumonia or angina, otitis, or sinusitis or persistent cough lasting more than 3 weeks, whatever the etiology or gastrointestinal pathology, involving vomiting, nausea, or diarrhoea.
• • With ongoing use of paracetamol, and/or homeopathic products against cough.
• • Having had corticosteroid treatment, antibiotics, antihistaminic or any cough medication (such as, but not limited to, Phytoxil, Arkotoux) in the previous 15 days since inclusion.
• • With a brother/sister already included in the present clinical investigation (If several children are eligible in the same household, only one will be enrolled at random).
• • Enrolled in another clinical trial or being in a period of exclusion from a previous clinical trial.