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Sinuclean's Treatment Of Sinusitis' Symptoms

NCT00747747 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2012-03-14

Study results available
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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.

Conditions

  • Sinusitis

Interventions

BIOLOGICAL

Saline solution

3 sprays per nostrils twice a day (morning and evening); in case of need a third nebulization between the two is allowed

DEVICE

Sinuclean DM Spray

3 sprays per nostrils twice a day (morning and evening); in case of need a third nebulization between the two is allowed

Sponsors & Collaborators

  • Galsor S.r.l.

    lead INDUSTRY

Principal Investigators

  • Gaetano Paludetti, MD · University Cattolica del Sacro Cuore Roma Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2009-01-31
Completion
2010-02-28

Countries

  • Italy

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 NCT00747747 on ClinicalTrials.gov