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

Last updated: November 12, 2024
Sponsor: Pierre Fabre Medicament
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pharyngitis

Treatment

Petit Drill

Clinical Study ID

NCT06688370
NIS17379
2023-A01929-36
  • Ages 6-6
  • All Genders

Study Summary

Demulcent or soothing substance is the currently recommended option to alleviate throat irritation associated to cough and sore throat in children under 6 years. The intended benefit to the patient of Petit Drill is to calm throat irritation (sore throat) associated to dry cough in infants starting at 6 months of age and in children up to 6 years of age. This intended benefit sustained by the properties of the formula is recognized and promoted by the World Health Organization, health authorities and current textbooks to have a positive impact on patient management for the targeted population (infant / child).

This study aims at assessing the effectiveness of the syrup in real-life context, in children presenting throat irritation to support the conclusion of clinical evaluation report.

Eligibility Criteria

Inclusion

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 participatingpharmacy in accordance with recommendations for use (regarding age and type ofcough);

  • For infants between 6 months and 12 months of age - a confirmed prescription from atreating 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 thenight before inclusion);

  • For whom child-minding will allow to respect the recommended daily doses of PetitDrill 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 thequestionnaires in timely manner;

  • With parent(s)/legal guardian who provide their signed informed consent for thechild's enrolment in the study.

Exclusion

Exclusion Criteria:

  • Presenting with one of the following conditions: Chronic respiratory illness such asasthma, recurrent wheezing associated to viral infections and bronchitis or lowerrespiratory infections, such as bronchitis, bronchiolitis, and pneumonia or angina,otitis, or sinusitis or persistent cough lasting more than 3 weeks, whatever theetiology 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 coughmedication (such as, but not limited to, Phytoxil, Arkotoux) in the previous 15 dayssince inclusion.

  • With a brother/sister already included in the present clinical investigation (Ifseveral children are eligible in the same household, only one will be enrolled atrandom).

  • Enrolled in another clinical trial or being in a period of exclusion from a previousclinical trial.

Study Design

Total Participants: 245
Treatment Group(s): 1
Primary Treatment: Petit Drill
Phase:
Study Start date:
March 12, 2024
Estimated Completion Date:
December 31, 2025

Study Description

Pediatric patients are recruited by pharmacist in community settings, who briefly present the clinical investigation to the parent who purchases Petit Drill for his/her child.

The pharmacist provides to interested parent the study inform note and transfer the parent's name and contact information to the clinical investigation centre. The parent is contacted to take part to the remote inclusion visit with a site investigator, scheduled within the day of Petit Drill delivery. Once consent has been signed, the investigator verifies eligibility criteria, then collects baseline data.

Follow-up lasts as long as the child receives the syrup, but no longer than 3 days and 3 nights. The parent completes daily questionnaires and record syrup intake in a secure mobile application for patient reported outcomes.

Connect with a study center

  • Cen Experimental

    Dijon, 21000
    France

    Active - Recruiting

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