CompletedNot Applicable

Safety and Effectiveness of Sonu for Pediatric Nasal Congestion

United States31 participantsStarted 2025-01-09

Plain-language summary

To demonstrate the safety and effectiveness of Sonu for the treatment of pediatric patients with moderate to severe nasal congestion.

Who can participate

Age range12 Years – 21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Pediatric subjects between the ages of 12 to 21 years * Present with symptoms of nasal congestion for 1 month or more prior to treatment * Have a 24 hour reflective nasal congestion subscore of the TNSS of 2 or more on a 0 to 3 scale at the time of screening Exclusion Criteria: * Head, nasal or sinus surgery within 3 months * Sinus infection diagnosed within the last month, or rhinitis medicamentosa * Documented history of nasal polyposis or mass * Pregnancy

What they're measuring

Serious adverse events

Timeframe: 2 weeks

Reduction in nasal congestion subscore

Timeframe: 2 weeks

Trial details

NCT IDNCT06773013

SponsorThird Wave Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-16

View on ClinicalTrials.gov More Nasal Congestion and Inflammations trials