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Sinuclean Nebules 45 for Treatment of Pediatric Exudative Otitis Media

NCT02858388 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2016-08-08

No results posted yet for this study

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.

Conditions

  • Otitis Media With Effusion

Interventions

DEVICE

Sinuclean Nebules 45

Nebulization of solution

OTHER

Saline solution

Nebulization of solution

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    collaborator OTHER

  • Galsor S.r.l.

    lead INDUSTRY

Principal Investigators

  • Attilio Varricchio, MD · San Gennaro Hospital, Naples, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-09-30
Completion
2015-12-31

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 NCT02858388 on ClinicalTrials.gov