Ignite Creation Date:
2024-05-06 @ 8:55 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02858388
Status:
COMPLETED
Last Update Posted:
2016-08-08
First Post:
2016-06-26
Brief Title:
Sinuclean Nebules 45 for Treatment of Pediatric Exudative Otitis Media
Sponsor:
Galsor Srl
Organization:
Galsor Srl
Study Overview
Official Title:
Safety and Efficacy of Sinuclean Nebules 45 Class 1 Medical Device in the Treatment of Pediatric Exudative Otitis Media Randomized Double Blind Comparative Parallel Study
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of the study is to investigate if the active agent of Sinuclean Nebules is efficacious in the treatment of pediatric exudative otitis media comparing with saline
Sinuclean Nebules is a solution of cucurbitacins BDIE glycosylated triterpenes 45 mcg extracted from Ecballium Elaterium
Sinuclean Nebules is a solution of cucurbitacins BDIE glycosylated triterpenes 45 mcg extracted from Ecballium Elaterium
Detailed Description:
Eligible pediatric subjects with diagnosis of mono or bi-lateral exudative otitis media obtained with otorhinolaryngologic endoscopic examination tympanogram and tonal audiometry are randomized to treatment with Sinuclean Nebules 45 or saline
Treatment is administered by trained caregiver with nebulizer Rinowash Nasal Shower one nebulizationnostrilday for two cycles of 10 consecutive days Cycles are interrupted by a period of 7 days
Visits 1 Baseline T0 confirmation of eligibility randomization training of caregiver dispensation of blinded therapy for two cycles delivery of the clinical diary
Visit 2 after 10 days of therapy 7 days of interval phone call to check for adverse events therapy adherence concomitant diseases and treatments and to prescribe second cycle of therapy
Visit 3 End of Study assessment of the exudative otitis media with otorhinolaryngologic endoscopic examination tympanogram tonal audiometry verification of the subjects clinical diary
Treatment is administered by trained caregiver with nebulizer Rinowash Nasal Shower one nebulizationnostrilday for two cycles of 10 consecutive days Cycles are interrupted by a period of 7 days
Visits 1 Baseline T0 confirmation of eligibility randomization training of caregiver dispensation of blinded therapy for two cycles delivery of the clinical diary
Visit 2 after 10 days of therapy 7 days of interval phone call to check for adverse events therapy adherence concomitant diseases and treatments and to prescribe second cycle of therapy
Visit 3 End of Study assessment of the exudative otitis media with otorhinolaryngologic endoscopic examination tympanogram tonal audiometry verification of the subjects clinical diary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None