Double-blind, randomized placebo controlled study on the effect from cortisone treatment of acute loss of vestibular or balance function of the inner ear - function, subjective well-being and stress

Conditions: Acute vestibular syndrome better known as Vestibular neuritis
MedDRA version: 17.1Level: LLTClassification code 10047392Term: Vestibular nerve damageSystem Organ Class: 100000004863
MedDRA version: 17.1Level: LLTClassification code 10047388Term: Vestibular function disorderSystem Organ Class: 100000004854
MedDRA version: 17.1Level: LLTClassification code 10051781Term: Vestibular paralysisSystem Organ Class: 100000004862
MedDRA version: 17.1Level: LLTClassification code 10013285Term: Disorder vestibularSystem Organ Class: 100000004854
Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

Registration Number: EUCTR2014-005484-32-SE

Lead Sponsor: und University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

-between 18 and 80 years of age
-disease duration <48hrs
-clinical vestibular neuritis and no other neurological symptoms
-no dangerous HINTS (examination procedure)
-informed consent
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 160
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

-history of perforated ulcus
-tinnitus and hearing loss that started at the same time as vertigo
-psychiatric disease requiring treatment (other than mild depression treated with SSRIs)
-chronic otitis media
-serious infection, neutropenia or tuberculosis
-pregnancy or not wanting to prevent pregnancy during the time of medication (11 days)
-blood pressure; systolic >180 and/or diastolic >110
-impaired ability to make decision (dementia or up to treating physician)
-diabetes with ketoacidosis (Base excess >=2)