An interventional study of IP1 - Stérimar BLOCKED NOSE Baby nasal spray and IP2 - Stérimar Stop & Protect Cold Baby + standard of care in Common Cold and Nasal Congestion, sponsored by Church & Dwight Company, Inc.. Terminated at 1 site in Italy. Open to participants aged 3 Months to 48 Months. Per ClinicalTrials.gov, last updated 2024-10-03.
Sponsored by Church & Dwight Company, Inc. · Not applicable, Interventional, and Treatment
Among 10 studies in Common Cold with a site in Italy — none open to participants now, none under way, none of them phase 3. Common Cold · Italy.
Among the 10 studies in Common Cold with a site in Italy, this one is the only one that started in 2021, is one of 5 with no phase, and was the 7th registered.
219 studies on the registry are indexed under Common Cold; 23 are open to participants now.
Browse Common Cold studies →None of the 10 studies in Common Cold with a site in Italy is open now. The open studies under Common Cold, anywhere →
Of the 14 Common Cold studies recruiting now, 4 (29%) set no upper age limit and 9 (64%) stop at 75 or younger; 4 take children under 18; 7 take healthy volunteers.
This study: 3 Months to 48 Months · all sexes · no healthy volunteers.
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10 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 1 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 9 is below the median of 150 across 184 interventional studies indexed under Common Cold.
Median enrollment 279 across the 9 interventional studies, 131 across the 1 observational. Of the 10 that completed or were terminated, 0 (0%) have results posted.
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7 of 10 have an industry lead sponsor. The 9 most frequent:
Church & Dwight Company, Inc. is the lead sponsor of 33 studies on the registry; none are open to participants now.
Church & Dwight Company, Inc. has 1 study filed under Common Cold — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Common Cold with a site in Italy, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The objective of this clinical trial is to evaluate the tolerance and efficacy of two Stérimar nasal sprays products in children who have nasal congestion due to the common cold.
This clinical trial is a multicentre, randomized, parallel-group, controlled, open-label clinical trial to evaluate the efficacy of two Stérimar nasal sprays formulations (medical device already CE marked) for nasal congestion in children aged 3 to 48 months with common cold. In total the study foresees 300 patients divided between the different clinical sites.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
IP1 - Stérimar BLOCKED NOSE Baby nasal spray + standard of care
Device: IP1 - Stérimar BLOCKED NOSE Baby nasal spray · Behavioral: Standard of Care
IP2 - Stérimar Stop \& Protect Cold Baby + standard of care
Device: IP2 - Stérimar Stop & Protect Cold Baby + standard of care · Behavioral: Standard of Care
Standard of Care alone
Behavioral: Standard of Care
1 to 2 sprays per nostril at least 2 twice a day and, as needed, up to a maximum of 6 times a day.
1 to 2 sprays per nostril at least 2 twice a day and, as needed, up to a maximum of 6 times a day.
hydration + rest at home + if needed paracetamol
Change of nasal congestion.
Assess change of nasal congestion, evaluated by means of a specific questionnaire ("Cold Symptom Severity" questionnaire), to be completed at Day 0 (baseline) and daily from the beginning to the end of the study; comparisons among groups A, B versus group C.
Time frame: Through study completion, an average of 10 days
Change of other cold symptoms.
Assess change of other cold symptoms, evaluated by means of a specific questionnaire ("Cold Symptom Severity" questionnaire), to be completed at Day 0 (baseline) and daily from the beginning to the end of the study; comparisons among groups; comparisons among groups A, B versus group C. Other cold symptoms: * Nasal crust (dry mucus) * Runny nose (drip/sniff/snorting/drainage/discharge) * Thick mucus * Sneezing * Cough.
Time frame: Through study completion, an average of 10 days
Occurrence of secondary infections.
Assessment of occurrence of secondary infections (number) daily, from the beginning to the end of the study; comparisons of group A, B versus group C. Secondary infections will be confirmed by the Investigator.
Time frame: Daily through the end of the study, approximately 10 days
Onset of relief.
Assessment of onset of relief (immediate relief) after the entire product application is completed (1 or 2 sprays) at Day 0 (baseline) and daily from Day 1 to Day 3 of the study; comparisons within groups A and B.
Time frame: Through study completion, an average of 10 days
Concomitant medications.
Assessment of use of concomitant medications (frequency, excluding paracetamol) will be done from the beginning to the end of the study; comparisons among groups A, B, C.
Time frame: Through study completion, an average of 10 days
Frequency of paracetamol administration.
Assessment of use of paracetamol (frequency) will be done from the beginning to the end of the study; comparisons within groups A, B, versus group C.
Time frame: Through study completion, an average of 10 days
Quality of sleep.
Assessment of quality of sleep will be evaluated by means of the "quality of sleep" questionnaire, to be completed at Day 0 (baseline) and daily from the beginning to the end of the study; comparisons within groups A, B versus group C.
Time frame: Through study completion, an average of 10 days
Global assessment on common cold status.
Global assessment on common cold status will be evaluated by means of the "global assessment on common cold status" questionnaire, to be completed from the beginning to the end of the study; comparisons within groups.
Time frame: Through study completion, an average of 10 days
Ran from Nov 2021 to primary completion in Mar 2023, 15 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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