Evaluating the effectiveness of Petit Drill for throat irritation in young children
The Performance and Safety of Petit Drill in the French Paediatric Population: a Post-market Clinical Follow-up.
This study is testing if a syrup called Petit Drill can help soothe throat irritation in young children with coughs and sore throats.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 245 (estimated) |
| Ages | 6 Months to 6 Years |
| Sex | All |
| Sponsor | Pierre Fabre Medicament Industry-sponsored |
| Locations | 1 site (Dijon) |
| Trial ID | NCT06688370 on ClinicalTrials.gov |
What this trial studies
This observational study assesses the effectiveness of Petit Drill, a syrup designed to soothe throat irritation associated with cough and sore throat in children aged 6 months to 6 years. Pediatric patients are recruited through community pharmacies, where parents are informed about the study and can consent to participate. Once enrolled, parents complete daily questionnaires and track syrup intake using a secure mobile application over a follow-up period of up to 3 days. The study aims to gather real-life data to support the clinical evaluation of Petit Drill.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 months to 6 years experiencing acute cough and throat irritation.
Not a fit: Patients with chronic cough or those not meeting the specific inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a validated treatment option for alleviating throat irritation in young children, improving their comfort and quality of life.
How similar studies have performed: While this approach is based on established practices, the specific evaluation of Petit Drill in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Dijon
- Cen Experimental — Dijon, France (Recruiting)
Study contacts
- Principal investigator: Vincent Alquier — Pharmacist
- Study coordinator: Didier Junquero
- Email: didier.junquero@pierre-fabre.com
- Phone: +33 6 42 46 35 17
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.