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Cough syrup study for infants and toddlers ends early

NCT ID NCT06688370

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

12 people

The number who actually took part.

Started

Mar 2024

Finished

Nov 2024

Lead sponsor

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

6 months to 6 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • Cen Experimental

    Dijon, 21000, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.