NCT02858388

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 8, 2016

Completed
Last Updated

August 8, 2016

Status Verified

August 1, 2016

Enrollment Period

8 months

First QC Date

June 26, 2016

Last Update Submit

August 3, 2016

Conditions

Otitis Media With Effusion

Keywords

Otitis Media with EffusionExudative otitis media

Outcome Measures

Primary Outcomes (1)

  • Resolution of tympanic effusion

    The resolution of the tympanic effusion will be assessed with tympanogram (% of subjects with type A tympanogram).

    At Day 28 after start of treatment

Secondary Outcomes (1)

  • Complete auditory recovery

    At Day 28 after start of treatment

Study Arms (2)

SN45

ACTIVE COMPARATOR

Sinuclean Nebules 45

Device: Sinuclean Nebules 45

Sal

PLACEBO COMPARATOR

Saline solution

Other: Saline solution

Interventions

Sinuclean Nebules 45DEVICE

Nebulization of solution

SN45
Saline solutionOTHER

Nebulization of solution

Sal

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Documented diagnosis of mono or bi-lateral exudative otitis media, performed the day of recruitment or in the week before, with endotympanic effusion present for at least 3 months, and hearing loss.
  • The diagnostic criteria is type B tympanogram for at least one of the two ears.
  • The criteria is integrated by a) tonal audiometry to demonstrate bilateral or monolateral deficit (loss of more than 20dB averaged to 0.5-1.2 and 4Khz in the best ear with pure tone audiometry); for 1-3 yo subjects the audiometry is behavioural b) otorhinolaryngologic examination in endoscopy for the otologic, rhino-sinusal and pharyngeal districts.

You may not qualify if:

  • Outcomes of adenotonsillectomy
  • Velo-palatal insufficiencies, cleft lip and cleft palate.
  • Hearing loss of perceptual, and mixed type.
  • Clinical conditions (systemic diseases or other) that may interfere with the evaluation of safety and clinical effectiveness of the product under investigation, for example: diabetes mellitus, heart disease, chronic renal failure, active systemic infections)
  • Assumption, during the study of drugs that may interfere with the assessment of the product object of clinical investigation.
  • Possibility of needing treatment during the study with drugs that are not allowed, for example: antibiotics in long-term prophylaxis, immunosuppressants, corticosteroids.
  • Regular intake of steroids in the four weeks preceding the date of the admission visit.
  • Viral or allergic rhinitis, with active effusion.
  • Down Syndrome
  • Diagnosis of immotile cilia syndrome
  • Condition of immune deficiency disease or otherwise.
  • Cystic Fibrosis.
  • Dental malocclusion
  • Other diseases of other organ systems, which, in the opinion of the investigator, may interfere with the purpose or the study procedures.
  • Not vaccinated subjects, with no clinical history of varicella who have been in contact, in the 4 weeks before the admission visit, with people who may be suffering from chicken pox or Zoster.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Gennaro Hospital

Naples, 80136, Italy

Location

Related Publications (1)

  • Zielhuis GA, Straatman H, Rach GH, van den Broek P. Analysis and presentation of data on the natural course of otitis media with effusion in children. Int J Epidemiol. 1990 Dec;19(4):1037-44. doi: 10.1093/ije/19.4.1037.

    PMID: 2083987BACKGROUND

MeSH Terms

Conditions

Otitis Media with Effusion

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Otitis MediaOtitisEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Attilio Varricchio, MD

    San Gennaro Hospital, Naples, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2016

First Posted

August 8, 2016

Study Start

January 1, 2015

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

August 8, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)