Clinical Trials Logo

Clinical Trial 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 B,D,I,E (glycosylated triterpenes) 45 mcg, extracted from Ecballium Elaterium.


Clinical Trial 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 nebulization/nostril/day 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 subject's clinical diary. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02858388
Study type Interventional
Source Galsor S.r.l.
Contact
Status Completed
Phase Phase 3
Start date January 2015
Completion date December 2015

See also
  Status Clinical Trial Phase
Completed NCT03590912 - Efficacy and Cost Analysis of Steroids in Treatment of Otitis Media With Effusion Phase 4
Completed NCT03611842 - Study of the Expression of MMPs in OME in Children With Atrophy of the Eardrum
Not yet recruiting NCT01421199 - Device Study to Evaluate the Detection and Characterization of Middle Ear Fluid in Children N/A
Completed NCT01202578 - Evaluation of the Tympanostomy Tube Delivery System Phase 2/Phase 3
Completed NCT00520039 - Osteopathic Otitis Media Research Study N/A
Completed NCT00629694 - Adenoidectomy, Myringotomy and Tubes' Insertion vs Adenoidectomy and Myringotomy Alone in Children With Otitis Media With Effusion and Adenoid Hypertrophy Phase 2
Completed NCT00195611 - Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media Phase 4
Not yet recruiting NCT05402267 - The Effects of Exosomes in Otitis Media With Effusion
Not yet recruiting NCT04584073 - Secretory Otitis Media in Adenoids Hypertrophy Patients N/A
Withdrawn NCT00736112 - Food Allergy - Tubes - Adenoids (FATA) Trial N/A
Completed NCT00546117 - A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion N/A
Withdrawn NCT02950311 - Xylitol for Otitis Media Phase 2/Phase 3
Recruiting NCT05324696 - Autoinflation: Alternative in the Treatment of Otitis Media With Effusion N/A
Recruiting NCT05353569 - Coherent Optical Detection of Middle Ear Disease N/A
Completed NCT02282540 - Novel Imaging of the Eustachian Tube; Patient Study N/A
Not yet recruiting NCT03491098 - The Efficacy of Nasal Steroids in Treatment of Otitis Media With Effusion: Acomparative Study Early Phase 1
Completed NCT01082029 - Study of Anti-reflux Medication as a Potential Treatment for Glue Ear in Children Phase 4
Completed NCT00939796 - Clinical Study of the Tympanostomy Tube Delivery System N/A
Recruiting NCT06316635 - Microplastics in Otitis Media With Effusion Material
Recruiting NCT02215681 - Acupuncture Effect on Inflammatory Markers in Pediatric Otitis Media With Effusion: A Pilot Study N/A