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Fludrocortisone for Sudden Hearing Loss

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2015 by Anh Nguyen-Huynh, Oregon Health and Science University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01186185
First Posted: August 23, 2010
Last Update Posted: April 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Anh Nguyen-Huynh, Oregon Health and Science University
August 19, 2010
August 23, 2010
April 22, 2015
August 2012
August 2016   (Final data collection date for primary outcome measure)
Hearing [ Time Frame: 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.
Same as current
Complete list of historical versions of study NCT01186185 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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
Intervention Model: Single Group Assignment
Masking: None (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.
 
Unknown status
20
August 2016
August 2016   (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
Sexes Eligible for Study: All
18 Years to 89 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01186185
IRB00006240
No
Not Provided
Not Provided
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
April 2015

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