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

  • STATUS
    Recruiting
  • End date
    Apr 30, 2023
  • participants needed
    300
  • sponsor
    Church & Dwight Company, Inc.
Updated on 19 March 2022
congestion
cold
cough
nasal congestion
rhinorrhea
sneezing
nasal spray

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.

Description

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.

Details
Condition Common Cold, Nasal Congestion
Treatment Standard of Care, IP1 - Stérimar BLOCKED NOSE Baby nasal spray, IP2 - Stérimar Stop & Protect Cold Baby + standard of care
Clinical Study IdentifierNCT05244148
SponsorChurch & Dwight Company, Inc.
Last Modified on19 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male and female infants and toddlers aged 3 - 48 months (inclusive) at enrolment (Day 0)
Caretaker(s) answering "yes" to the question "Do you feel that your child has a cold?" at enrolment (Day 0)
Subjects with symptoms started within 48 hours prior to enrolment (Day 0)
Subjects with nasal congestion (blocked / stuffy nose) rated as at least grade 2 (moderately bothersome) on a 0 to 2-point scale, based on morning evaluation (within an hour of subject awakening)
Subjects showing at least grade 2 on a 0 to 2-point scale for at least one of the following additional signs of cold symptoms: runny nose, nasal crust (dry mucus), thick mucus, sneezing and cough
Legal caretaker(s) signed written informed consent for their young ones to participate in the study
Legal caretaker(s) willing to comply with all study procedures
Ability of the caretaker(s) (in the Investigator's opinion) to comprehend the full nature, procedures, and purpose of the study

Exclusion Criteria

Subjects presenting a body temperature greater than 38°C measured with a non-contact infrared thermometer at enrolment (Day 0)
Subjects presenting any secondary infection (such as bronchitis, otitis, tracheitis, pneumonia, and so on) at enrolment (Day 0)
Subjects with positive results on a streptococcal antigen screening test (rapid antigen detection test or RADT) at enrolment (Day 0)
Subjects with history of allergic rhinitis
Subjects presenting any congenital or chronic disease that in the opinion of the Investigator would adversely affect the results of the study (e.g., asthma, pneumonia, laryngotracheobronchitis, sinusitis, and so on)
Subjects presenting any kind of immunodeficiency
Subjects presenting any hypersensitivity or allergy or intolerance to any component of the study products
Subjects with a positive medical history to any significant illness within the 2 weeks prior to the enrolment (Day 0)
Subjects presenting any active systemic infection or medical condition that may require treatment or therapeutic intervention during the study
Subjects currently participating or having participated in another clinical trial during the last 30 days prior to enrolment (Day 0)
Subjects using saline nose drops or nasal sprays or pumps other than the study products, antibiotics, antivirals, intranasal medicines, decongestants, antihistamines, echinacea, combination cold formulas, supplements containing ≥ 10 mg zinc that would influence symptoms scores at enrolment (Day 0) within 12 hours prior the day of screening
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note