drugset / Trial / NCT00747747

Sinuclean's Treatment Of Sinusitis' Symptoms

NCT00747747 ↗

Phase 4 Completed 49 enrolled Galsor S.r.l.
RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of the study is to demonstrate that SINUclean DM® spray, added to the standard (amoxicillin/clavulanate) therapy of the acute episode of sinusitis (acute, subacute or chronic), is safe ad capable to determine the resolution of the symptoms in a shorter time in comparison with the standard therapy without co-adjuvant, or with simple saline lavage.

Timeline

Start
2007-11
Primary completion
2009-01
Completion
2010-02

Outcome

Met primary endpoint

registry NUMBER Control: 71 percentage of patients NUMBER Saline Treated.: 57 percentage of patients NUMBER Sinuclean Treated.: 33 percentage of patients NCT00747747 ↗

registry analysis (superiority or other test); Control vs Saline Treated. vs Sinuclean Treated.; p <0.05; Frequency 0; Chi-squared NCT00747747 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Sinuclean DM Spray Unknown — Intranasal

Indications