Adults 6 Months to 6, any sex, with Sore-throat or Cough. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Changes in the Pediatric Cough Questionnaire (PCQ) Total Score - Percentage of Children With a 3-point Decrease From Baseline After up to 3-day Treatment With Petit DrillPrimary· up to 3 days
Percentage of children with a 3 point-decrease (minimal clinical significance) of the Pediatric Cough Questionnaire (PCQ) total score from baseline after up to 3 day-treatment with Petit Drill.
PCQ refers to a past night recall of 5 questions, each scored from 0 "Not at all" to 5 "Extremely" using a 6-point Likert scale.
PCQ Total score consists of the sum of each score and ranges from 0 to 25.
Group
Value
95% CI
Petit Drill
7
Petit Drill AdherenceSecondary· Day 1, day 2 and day 3
Average number of times Petit Drill is administered in each 24-hour period
At least 1 day with 3 doses
Group
Value
95% CI
Petit Drill
6
1 day with 4 doses
Group
Value
95% CI
Petit Drill
1
less than 3 doses received at all days
Group
Value
95% CI
Petit Drill
5
Parent's Satisfaction With Petit DrillSecondary· Day 3
Satisfaction is assessed using a study specific questionnaire. Responses measured using Likert scales. Not validated Questionnaire; 6 questions with different way to answers.
Of note, parents were not considered enrolled but did contribute to this assessment.
Quality of therapeutic management: excellent
Group
Value
95% CI
Petit Drill
2
Quality of therapeutic management: good
Group
Value
95% CI
Petit Drill
5
Quality of therapeutic management: fair
Group
Value
95% CI
Petit Drill
1
Quality of therapeutic management: poor
Group
Value
95% CI
Petit Drill
1
Response to the child's needs: almost all were met
Group
Value
95% CI
Petit Drill
2
Response to the child's needs: most were met
Group
Value
95% CI
Petit Drill
4
Response to the child's needs: only few were met
Group
Value
95% CI
Petit Drill
3
Response to the child's needs: none were met
Group
Value
95% CI
Petit Drill
0
Petit Drill SafetySecondary· 3 days
Number of participants with adverse events and adverse device effects coded by using the System Organ Class (SOC) and Preferred Term (PT) of the version 24.1 of the Medical Dictionary for Regulatory Activities (MedDRA) dictionary.
Adverse events
Group
Value
95% CI
Petit Drill
4
Serious adverse events
Group
Value
95% CI
Petit Drill
0
Adverse device effect related to procedures
Group
Value
95% CI
Petit Drill
1
Adverse device effect related to device deficiency
Group
Value
95% CI
Petit Drill
1
Adverse event leading to permanent discontinuation
Group
Value
95% CI
Petit Drill
1
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were collected over days D1, D2, D3, D4.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
NCT06766253 — The Effects of GMA-TULIP, I-gel, and BlockBuster Laryngeal Mask in Laparoscopic Surgeries With Trendelenburg Position Un
· NA
· recruiting
NCT06690489 — An Observational Real-world Study to Evaluate the Impact of Dermatological Toxicities on the Quality of Life in Patients
· completed
NCT06669117 — FIH Trial of VERT-002 in Patients With Locally Advanced or Metastatic Solid Tumors With MET Alterations
· Phase 1, PHASE2
· recruiting
NCT06043817 — First-In-Human Study of STX-721/PFL-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer H
· Phase 1, PHASE2
· recruiting
NCT07096206 — Characteristics and Impacts of X-linked Hypohidrotic Ectodermal Dysplasia (XLHED) in Boys: An Observational Internationa
· active not recruiting
NCT06623773 — Study on Structum® in Adult Patients With Osteoarthritis (TRUST)
· completed
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pierre Fabre Medicament
Last refreshed: 23 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06688370.