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Fludrocortisone for Sudden Hearing Loss

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ClinicalTrials.gov Identifier: NCT01186185
Recruitment Status : Unknown
Verified April 2015 by Anh Nguyen-Huynh, Oregon Health and Science University.
Recruitment status was:  Recruiting
First Posted : August 23, 2010
Last Update Posted : April 22, 2015
Sponsor:
Information provided by (Responsible Party):
Anh Nguyen-Huynh, Oregon Health and Science University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Hearing Loss, Sensorineural Drug: Fludrocortisone Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mineralocorticoid Treatment for Sudden Sensorineural Hearing Loss
Study Start Date : August 2012
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Fludrocortisone Drug: Fludrocortisone
Fludrocortisone 0.2 mg by mouth daily for 30 days


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01186185


Contacts
Contact: Anh Nguyen-Huynh, MD PhD 503-494-8135 nguyanh@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Anh Nguyen-Huynh    503-260-9192    nguyanh@ohsu.edu   
Principal Investigator: Anh Nguyen-Huynh, MD PhD         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Anh Nguyen-Huynh, MD PhD Oregon Health and Science University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Anh Nguyen-Huynh, Assistant Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01186185     History of Changes
Other Study ID Numbers: IRB00006240
First Posted: August 23, 2010    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: April 2015

Keywords provided by Anh Nguyen-Huynh, Oregon Health and Science University:
sudden
sensorineural
hearing loss
 fludrocortisone
mineralocorticoid
steroid

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
 Nervous System Diseases
Signs and Symptoms
Fludrocortisone
Mineralocorticoids
Anti-Inflammatory Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs