Cough syrup study for infants and toddlers ends early
NCT ID NCT06688370
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how well Petit Drill syrup works and how safe it is for calming throat irritation and dry cough in children from 6 months to 6 years old. The syrup is a soothing substance recommended by the World Health Organization for this age group. The study planned to track changes in cough symptoms using a parent questionnaire, but it was stopped early after enrolling only 12 participants. Because it ended early, the results are limited.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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12 people
The number who actually took part.
- Started
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Mar 2024
- Finished
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Nov 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Pediatric population presented with acute dry cough
- Ages
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6 months to 6 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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; * 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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cen Experimental
Dijon, 21000, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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