Sore-throatTouxpetitNCT06688370

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

An observational study of Sore-throat and Cough, run by Pierre Fabre Medicament at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 6 months to 6 years
Conditions the study is for: Sore-throat, Cough
What is being tested?: Petit Drill
Type of treatment: Pill or oral medicine, Medical device
How many people: 12 participants
Where: 1 siteFrance
Study dates: 14 Mar 2024to 7 Nov 2024
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 months to 6 years
All sexes
No healthy volunteers
Child

Study population: Pediatric population presented with acute dry cough

Who may be able to join

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 dry 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;

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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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

France1 site

Cen Experimental
Dijon, 21000

Other trials in France

About this study

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

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.

Read the detailed description

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.

Conditions: Sore-throat, Cough
Being tested: Petit Drill
Keywords: dry cough, Petit Drill, throat irritation, sore throat
Medical subject headings: Pharyngitis, Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Petit DrillDevice
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.

Study groups in NCT06688370
Study group	Role	What they receive
Petit Drill		Participants who received treatment with the syrup (at least once) as long as necessary from D1 to D3, according to parent's judgement. Receives: Device: Petit Drill

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: up to 3 days

Secondary outcomes (3)

Petit Drill Adherence
Average number of times Petit Drill is administered in each 24-hour period
Measured: 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.
Measured: 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.
Measured: 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Mar 20247 Nov 2024

First posted14 Nov 2024
Study start14 Mar 2024
Primary completion7 Nov 2024
Study completion7 Nov 2024

Why it stopped: Due to difficulty in recruiting patients, the Sponsor decided to prematurely stop the study

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Sore-throatStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06688370
Sponsor's protocol ID: NIS17379
Other IDs: 2023-A01929-36
Acronym: Touxpetit
Status last verified: Dec 2025
First submitted: 15 Mar 2024
Last updated: 23 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sore-throat trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Performance and Safety of Petit Drill in the French Paediatric Population: a Post-market Clinical Follow-up.
ClinicalTrials.gov ID: NCT06688370
Acronym / sponsor ID: Touxpetit / NIS17379
Conditions: Sore-throat, Cough
Keywords: dry cough, Petit Drill, throat irritation, sore throat
Study type: Observational
Recruitment status: TerminatedReason stopped: Due to difficulty in recruiting patients, the Sponsor decided to prematurely stop the study
Enrolment: 12 participants (actual)
Lead sponsor: Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
Collaborators: CEN Biotech
Study start: 14 Mar 2024 (actual)
Primary completion: 7 Nov 2024 (actual)
Study completion: 7 Nov 2024 (actual)
First posted: 14 Nov 2024 (actual)
Results: Posted 23 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Petit Drill	–	Device: Petit DrillParticipants who received treatment with the syrup (at least once) as long as necessary from D1 to D3, according to parent's judgement.

Who may qualify

Ages: 6 months to 6 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
Study population: Pediatric population presented with acute dry cough

Key inclusion criteria (9 listed)

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 dry 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);

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Petit DrillDay 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.	Device	Petit Drill

Primary outcome

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
Time frame: 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.

3 secondary outcomes

Petit Drill Adherence
Time frame: Day 1, day 2 and day 3
Parent's Satisfaction With Petit Drill
Time frame: Day 3
Petit Drill Safety
Time frame: 3 days

Results and safety

Results posted to the registry on 23 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Petit Drill	12	7

Primary outcome: 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

Time frame: up to 3 days. Count of participants. Unit: Participants

Measure	Petit Drill n = 7
Value	7

Population analysed: Performance population which consists of all patients from the safety population without any major deviation from the protocol and for whom at least one evaluation of the primary outcome is available after treatment initiation (baseline and last assessment) and whose parent(s) or legal guardian did not withdraw their consent at any time. Due to the premature study discontinuation, analysis initially planned was not done, and all study outcomes were analyzed using descriptive statistics.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected over days D1, D2, D3, D4. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Petit Drill	0 of 12 (0%)	4 of 12 (33.3%)	0 of 12

Limitations and caveats (from the sponsor): The main limitation of this study is the very small number of patients included and analyzed (12 patients in the safety analysis; 7 in performance), because the study had been stopped prematurely due to major recruitment difficulties.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Sore-throat

Not yet recruiting
Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

VINCENT ALQUIER principal investigator

Pharmacist

GUY DUTAU study chair

pediatrician pulmologist

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Sore-throat and Cough, run by Pierre Fabre Medicament at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: up to 3 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06688370.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.