NCT01186185

Fludrocortisone for Sudden Hearing Loss

Mineralocorticoid Treatment for Sudden Sensorineural Hearing Loss

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Oregon Health and Science University · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hearing Loss, Sensorineural

Interventions

Type	Name	Description
DRUG	Fludrocortisone	Fludrocortisone 0.2 mg by mouth daily for 30 days

Timeline

• Start date: 2012-08-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2010-08-23
• Last updated: 2019-10-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study