CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 49 enrolled
Drug / intervention
Saline solution +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00747747
NCT00747747Phase 4Completed
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Safety and Efficacy (for Symptoms Remission) of the Treatment of the Acute Episode of Sinusitis With Ecballium Elaterium (SINUclean DM® Nasal Spray) as Co-adjuvant of the Antibiotic Therapy: Comparative, Prospective, Randomized, Open Study.

Galsor S.r.l.·interventional·Posted Sep 5, 2008·Updated Mar 14, 2012

In Brief

A Phase 4 clinical trial evaluating Saline solution and Sinuclean DM Spray for Sinusitis. Completed, enrolled 49 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSinusitis
CountriesItaly
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 5, 2008
Enrollment StartNov 1, 2007
Primary CompletionJan 1, 2009
Study CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 17.8 years ago

Interventions

Saline solutionbiological

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

Sinuclean DM Spraydevice

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