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Two Seawater-based Formulations for Relief of Nasal Congestion in Paediatric Subjects

NCT05244148 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-10-03

No results posted yet for this study

Summary

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.

Conditions

  • Common Cold
  • Nasal Congestion

Interventions

DEVICE

IP1 - Stérimar BLOCKED NOSE Baby nasal spray

1 to 2 sprays per nostril at least 2 twice a day and, as needed, up to a maximum of 6 times a day.

DEVICE

IP2 - Stérimar Stop & Protect Cold Baby + 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.

BEHAVIORAL

Standard of Care

hydration + rest at home + if needed paracetamol

Sponsors & Collaborators

  • Evidilya S.r.l.

    collaborator INDUSTRY

  • Church & Dwight Company, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
48 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-25
Primary Completion
2023-03-20
Completion
2023-03-20

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05244148 on ClinicalTrials.gov