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

Arm | Intervention/treatment |
---|---|
Experimental: Fludrocortisone |
Drug: Fludrocortisone
Fludrocortisone 0.2 mg by mouth daily for 30 days
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- 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.

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Ages Eligible for Study: | 18 Years to 89 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Contact: Anh Nguyen-Huynh, MD PhD | 503-494-8135 | nguyanh@ohsu.edu |
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 |
Principal Investigator: | Anh Nguyen-Huynh, MD PhD | Oregon Health and Science University |
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 |