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Evaluation of Corticosteroids on Idiopathic Sudden Sensorineural Hearing Loss - Sudden deafness

Evaluation of Corticosteroids on Idiopathic Sudden Sensorineural Hearing Loss - Sudden deafness

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-001487-32-SE
Enrollment
200
Registered
2005-09-27
Start date
2005-12-14
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopatic Sudden Sensorineural Hearing Loss

Interventions

Product Name: Prednisolon Product Code: Prednisolonum Pharmaceutical Form: Capsule* INN or Proposed INN: Prednisolon Concentration unit: mg milligram(s) Concentration type: equal Concentration number:

Sponsors

Linköping University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with sudden onset of Hearing loss developing within 24 hours whitout known etiology and with a hearing loss extended to 30dB or more in at least three contiguous frequencies of the audiogram and less than 7 days from onset to the first visit at the ENT-clinics. 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

Exclusion criteria: 1. Pregnancy 2. Diabetes 3. Chronic infections 4. Peptic Ulcer 5. Incompensated heard disease 6. Resently undergone surgery of inner organs. 7. Psychiatric disease

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the efficacy of Corticosteroids on Sudden Sensorineural Hearing Loss.;Secondary Objective: ;Primary end point(s): Three months after treatment a pure tone audiogram is evaluated. A difference in the frequency bands effected by the disease of >10dB between the prednisolon treated group compared to the placebo group will be in favour of corticosteroid therapy.

Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026