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A Nasal Spray for Relief of Nasal Congestion in Infants and Toddlers With Common Cold

NCT05365789 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2023-10-26

No results posted yet for this study

Summary

The study will evaluate the safety and efficacy of the study medical device plus standard of care versus standard of care in subjects between 3 and 48 months (inclusive) presenting symptoms of a common cold.

Conditions

  • Nasal Congestion

Interventions

DEVICE

Blocked Nose Baby nasal spray

One or two nasal sprays will be administered to each nostril for a minimum of 2 times per day up to a maximum of 6 times per day for a maximum of 10 days.

OTHER

Standard of care

Standard of care consists of hydration, rest at home and antipyretic paracetamol as necessary.

Sponsors & Collaborators

  • Church & Dwight Company, Inc.

    lead INDUSTRY

Principal Investigators

  • Anna Rynkiewicz, MD · Private Practice

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
48 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-20
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • Poland

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 NCT05365789 on ClinicalTrials.gov