Fludrocortisone for Sudden Hearing Loss

Early Phase 1

Terminated

• Conditions: Hearing Loss, Sensorineural
• Interventions: Drug: Fludrocortisone

• Registration Number: NCT01186185
• Lead Sponsor: Oregon Health and Science University

Brief Summary

The standard of care treatment of sudden hearing loss uses a type of steroid called glucocorticoid. Examples of glucocorticoids are prednisone, methylprednisolone and dexamethasone. Not everybody recovers hearing with glucocorticoid treatment. Fludrocortisone is a different type of steroid called mineralocorticoid. Unlike glucocorticoids, which work by reducing inflammation, mineralocorticoids work by changing salt and fluid balance. In animal studies, fludrocortisone is at least as effective as glucocorticoid in preserving hearing. Fludrocortisone is not approved for the treatment of sudden hearing loss. The purpose of this study is to test whether fludrocortisone can treat sudden hearing loss.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-19
• Study First Submitted QC: 2010-08-20
• Study First Posted: 2010-08-23
• Study Start: 2012-08
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-15
• Last Update Posted: 2019-10-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Age 18 or older
• Idiopathic sudden sensorineural hearing loss within 3 months
• Failure to recover hearing with glucocorticoid treatment or inability to tolerate glucocorticoid

Exclusion Criteria

• Other diagnosis for the sudden hearing loss
• Concurrent systemic use of another steroid
• Hypersensitivity to fludrocortisone
• Systemic fungal infection
• Hypertension requiring two or more medications
• Pitting edema
• Cardiomegaly
• Congestive heart failure
• Electrolyte abnormality
• Concurrent use of barbiturates, phenytoin, fosphenytoin, rifampin, or rifapentine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fludrocortisone	Fludrocortisone	-

Primary Outcome Measures

Name	Time	Method
Hearing	At one month	Hearing outcome will be determine by pure-tone and speech audiometry measured at the completion of a one-month course of treatment and compared with pre-treatment test results.

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States