Fludrocortisone for Sudden Hearing Loss

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2016-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hearing Loss, Sensorineural

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fludrocortisone

Group Type EXPERIMENTAL

Fludrocortisone

Intervention Type DRUG

Fludrocortisone 0.2 mg by mouth daily for 30 days

Interventions

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Fludrocortisone

Fludrocortisone 0.2 mg by mouth daily for 30 days

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No