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NCT05821842: SCORE

Sonu Nasal Congestion Relief Study in Patients Suffering From Moderate to Severe Nasal Congestion

Completed NA Results posted Last updated 26 April 2024
What this trial tests

NA trial testing Sonu in Nasal Congestion and Inflammations in 52 participants. Completed in 30 June 2023.

Timeline
23 March 2022
Primary endpoint
30 April 2023
30 June 2023

Quick facts

Lead sponsorThird Wave Therapeutics
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment52
Start date23 March 2022
Primary completion30 April 2023
Estimated completion30 June 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Third Wave Therapeutics

Who can join

18 and older, any sex, with Nasal Congestion and Inflammations. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Primary Effectiveness Primary · 2 weeks

Change in nasal congestion sub-score compared to baseline. The nasal congestion sub-score is reported on a scale of 0-3. 0 is the minimum and 3 is the maximum. Higher scores mean worse outcomes.

GroupValue95% CI
Sonu Treatment Group-0.87-1.11 – -0.62
Sham Control Group-0.44-0.64 – -0.23
Secondary Effectiveness Secondary · 2 weeks

Change in total nasal symptom score (TNSS) compared to baseline. The TNSS is the sum of four (4) symptom sub-scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each self-rated by the subject using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. TNSS scores are reported on a scale of 0-12. 0 is the minimum and 12 is the maximum. Higher scores mean worse outcomes.

GroupValue95% CI
Sonu Treatment Group-2.85-3.85 – -1.85
Sham Control Group-1.32-2.27 – -0.36

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other Third Wave Therapeutics trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05821842.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing