Fludrocortisone for Sudden Hearing Loss

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Oregon Health and Science University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Anh Nguyen-Huynh, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01186185
First received: August 19, 2010
Last updated: August 19, 2011
Last verified: August 2011

August 19, 2010
August 19, 2011
August 2010
August 2012   (final data collection date for primary outcome measure)
Hearing [ Time Frame: At one month ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01186185 on ClinicalTrials.gov Archive Site
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Fludrocortisone for Sudden Hearing Loss
Mineralocorticoid Treatment for Sudden Sensorineural Hearing Loss

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hearing Loss, Sensorineural
Drug: Fludrocortisone
Fludrocortisone 0.2 mg by mouth daily for 30 days
Experimental: Fludrocortisone
Intervention: Drug: Fludrocortisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 89 Years
No
Contact: Anh Nguyen-Huynh, MD PhD 503-494-8135 nguyanh@ohsu.edu
Contact: Yong-Bing Shi, MD PhD 503-494-7954 shib@ohsu.edu
United States
 
NCT01186185
IRB00006240
No
Anh Nguyen-Huynh, Oregon Health and Science University
Oregon Health and Science University
Not Provided
Principal Investigator: Anh Nguyen-Huynh, MD PhD Oregon Health and Science University
Oregon Health and Science University
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP