Combined steroid therapy in sudden hearing loss

Combinated systemic and intratympanic steroid therapy in idiopathic sudden sensorineural hearing loss

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000658-20-HU

Enrollment

100

Registered

2017-02-24

Start date

2017-04-24

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

Idiopathic Sudden Sensorineural Hearing Loss

Interventions

Product Name: dexamethason acis 40mg Product Code: 14.11.1966/14.11.2001 Pharmaceutical Form: Intravesical solution/solution for injection INN or Proposed INN: DEXAMETHASONE DIHYDROGEN PHOSPHATE DISOD

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Unilateral sensorineural hearing loss (30 dB at three consecutive frequencies) within 72 hours, older than 18 years old 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: Pregnant or breast-feed

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the trial is to compare hearing result in ISSHL patient who have recieved combined steroid therapy with systemic steroid therapy alone;Secondary Objective: Not applicable;Primary end point(s): Our goal is to prove that hearing recovery after ISSNHL is significantly better in the combination therapy group than in the only systemic therapy group.;Timepoint(s) of evaluation of this end point: 2 years	—

Measure

Time frame

Main Objective: The main objective of the trial is to compare hearing result in ISSHL patient who have recieved combined steroid therapy with systemic steroid therapy alone;Secondary Objective: Not applicable;Primary end point(s): Our goal is to prove that hearing recovery after ISSNHL is significantly better in the combination therapy group than in the only systemic therapy group.;Timepoint(s) of evaluation of this end point: 2 years

—

Secondary

Measure	Time frame
Secondary end point(s): No further side effects in case of intratympanic steroid application;Timepoint(s) of evaluation of this end point: 2 years	—

Countries

Hungary

Outcome results

None listed

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