An observational study in Sore-throat and Cough, sponsored by Pierre Fabre Medicament. Terminated at 1 site in France. Open to participants aged 6 Months to 6 Years. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by Pierre Fabre Medicament (part of Pierre Fabre) · Observational
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.
Pediatric patients were recruited by pharmacist in community settings, who briefly presented the clinical investigation to the parent who purchases Petit Drill for his/her child.
The pharmacist provided the interested parent with the study information note and transferred the parent's name and contact details to the clinical investigation centre. The parent was then contacted to take part in the remote inclusion visit with a site investigator, scheduled on the same day of Petit Drill delivery. During the inclusion visit, once consent has been signed, the investigator verified eligibility criteria, and collected baseline data.
The follow-up periods lasted as long as the child received the syrup, but it should not exceed 3 days and 3 nights. The parent completed daily questionnaires and recorded the child's syrup intake in a secure mobile application designed for patient reported outcomes (PROs).
Of note, due to the premature discontinuation of the study, all statistical analyses initially planned in the Statistical Analysis Plan (SAP) were not conducted. All study outcomes were analyzed using descriptive statistics. Therefore, results presented hereafter are limited to few study outcomes.
427 studies on the registry are indexed under Cough; 67 are open to participants now.
This study's enrollment of 12 is below the median of 100 across 95 observational studies indexed under Cough.
Browse Cough studies →Pierre Fabre Medicament is the lead sponsor of 73 studies on the registry; 6 are open to participants now.
Compared within Cough, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pharyngitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Pediatric population presented with acute dry cough
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants who received treatment with the syrup (at least once) as long as necessary from D1 to D3, according to parent's judgement.
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.
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 Drill
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.
Time frame: up to 3 days
Petit Drill Adherence
Average number of times Petit Drill is administered in each 24-hour period
Time frame: Day 1, day 2 and day 3
Parent's Satisfaction With Petit Drill
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.
Time frame: Day 3
Petit Drill Safety
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.
Time frame: 3 days
| Milestone | Petit Drill |
|---|---|
| Started | 12 |
| Completed | 7 |
| Not completed | 5 |
| Withdrew: Discontinued the treatment | 1 |
| Withdrew: Prohibited treatment taken | 4 |
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.
| Participants | Petit Drill |
|---|---|
| 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 Drill | 7 |
Average number of times Petit Drill is administered in each 24-hour period
| Participants | Petit Drill |
|---|---|
| At least 1 day with 3 doses | 6 |
| 1 day with 4 doses | 1 |
| less than 3 doses received at all days | 5 |
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.
| Participants | Petit Drill |
|---|---|
| Quality of therapeutic management: excellent | 2 |
| Quality of therapeutic management: good | 5 |
| Quality of therapeutic management: fair | 1 |
| Quality of therapeutic management: poor | 1 |
| Response to the child's needs: almost all were met | 2 |
| Response to the child's needs: most were met | 4 |
| Response to the child's needs: only few were met | 3 |
| Response to the child's needs: none were met | 0 |
| Willingness to recommend the syrup: yes generally | 2 |
| Willingness to recommend the syrup: yes definitely | 5 |
| Willingness to recommend the syrup: no | 2 |
| Satisfaction with information from Instruction For Use (IFU) to use treatment: quite dissatisfied | 0 |
| Satisfaction with information from IFU to use treatment: indifferent or mildly dissatisfied | 0 |
| Satisfaction with information from IFU to use treatment: mostly satisfied | 6 |
| Satisfaction with information from IFU to use treatment: very satisfied | 3 |
| Ease of syrup use: yes generally | 2 |
| Ease of syrup use: yes definitely | 7 |
| Ease of syrup use: no | 0 |
| Feeling that the child enjoyed the syrup taste: yes generally | 2 |
| Feeling that the child enjoyed the syrup taste: yes definitely | 7 |
| Feeling that the child enjoyed the syrup taste: no | 0 |
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.
| Participants | Petit Drill |
|---|---|
| Adverse events | 4 |
| Serious adverse events | 0 |
| Adverse device effect related to procedures | 1 |
| Adverse device effect related to device deficiency | 1 |
| Adverse event leading to permanent discontinuation | 1 |
Collected over Adverse events were collected over days D1, D2, D3, D4. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Petit Drill | 0/12 (0%) | 0/12 (0%) | 4/12 (33.3%) |
| Event | Petit Drill |
|---|---|
| CoughRespiratory, thoracic and mediastinal disorders | 1/12 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 1/12 |
| TonsilitisRespiratory, thoracic and mediastinal disorders | 1/12 |
| UnderdoseInjury, poisoning and procedural complications | 1/12 |
| Device use errorInjury, poisoning and procedural complications | 1/12 |
| VomitingGastrointestinal disorders | 1/12 |
| FatigueGeneral disorders | 1/12 |
Full Analysis Set (FAS) population: the analysis population consists of patients who were included in this clinical investigation after fulfilling all eligibility criteria.
| Age, Continuous(year) | Petit Drill |
|---|---|
| Mean | 3.1 ± 1.9 |
| Sex: Female, Male(Participants) | Petit Drill |
|---|---|
| Female | 7 |
| Male | 5 |
| Race and Ethnicity Not Collected(Participants) | Petit Drill |
|---|
| Rank of sibling(Participants) | Petit Drill |
|---|---|
| Single child | 3 |
| First | 4 |
| Second | 2 |
| Third | 2 |
| Fourth | 1 |
| Description of study population (home region)(Participants) | Petit Drill |
|---|---|
| Bourgogne Franche-Comté | 1 |
| Centre-Val de Loire | 1 |
| Grand Est | 3 |
| Hauts-de-France | 2 |
| Nouvelle-Aquitaine | 3 |
| Occitanie | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Mar 2024 to primary completion in Nov 2024, 7 months.
Results were first posted in Dec 2025, 1 year 1 month after primary completion.
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