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

NCT06688370 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2025-12-23

Study results available
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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 aimed at assessing the performance of the syrup in real-life context, in children presenting throat irritation associated with dry cough to support the conclusion of clinical evaluation report.

Conditions

Interventions

DEVICE

Petit Drill

Day 1: 2-4 doses, including one of the daily doses taken at bedtime. Days 2 and 3: 3 to 4 doses, including one of the daily doses taken at bedtime.

Sponsors & Collaborators

  • CEN Biotech

    collaborator INDUSTRY

  • Pierre Fabre Medicament

    lead INDUSTRY

Principal Investigators

  • VINCENT ALQUIER · Pharmacist

  • GUY DUTAU · pediatrician pulmologist

Eligibility

Min Age
6 Months
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-14
Primary Completion
2024-11-07
Completion
2024-11-07

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06688370 on ClinicalTrials.gov