?Idiopathic sudden sensorineural hearing loss treatment by Infliximab injection (TNF-alfa blocker)? - ND

• Conditions: idiopathic sudden hearing loss; MedDRA version: 9.1Level: HLTClassification code 10027666Term: Ear disorders NEC

• Registration Number: EUCTR2007-004074-10-IT
• Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-04
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

idiopathic sudden sensorineural hearing loss (severe or profound pure tone average) no responders to protocol therapy; caucasian race subjects; age range 20-80 years; female and males.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

familiar history of hearing loss; immunodeficiency disease; severe heart and vascular disease; pharmacological intolerance; cases responders to protocol therapy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to evaluate therapeutic effect;Secondary Objective: nd;Primary end point(s): nd