Fludrocortisone for Sudden Hearing Loss
Information source: Oregon Health and Science University
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hearing Loss, Sensorineural
Intervention: Fludrocortisone (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Oregon Health and Science University Official(s) and/or principal investigator(s):
Anh Nguyen-Huynh, MD PhD, Principal Investigator, Affiliation: Oregon Health and Science University
Overall contact:
Anh Nguyen-Huynh, MD PhD, Phone: 503-494-8135, Email: nguyanh@ohsu.edu
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.
Clinical Details
Official title: Mineralocorticoid Treatment for Sudden Sensorineural Hearing Loss
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Hearing
Eligibility
Minimum age: 18 Years.
Maximum age: 89 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Anh Nguyen-Huynh, MD PhD, Phone: 503-494-8135, Email: nguyanh@ohsu.edu
Oregon Health & Science University, Portland, Oregon 97239, United States; Recruiting
Anh Nguyen-Huynh, Phone: 503-260-9192, Email: nguyanh@ohsu.edu
Yong-Bing Shi, MD PhD, Phone: 503-494-7954, Email: shib@ohsu.edu
Anh Nguyen-Huynh, MD PhD, Principal Investigator
Yong-Bing Shi, MD PhD, Sub-Investigator
Additional Information
Starting date: August 2010
Last updated: August 19, 2011
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