View Clinical Trial (Medical Research Study)
Mineralocorticoid Treatment for Sudden Sensorineural Hearing Loss
| City: |
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Portland |
| State: |
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Oregon |
| Zip Code: |
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97239 |
| Conditions: |
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Hearing Loss, Sensorineural |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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
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| NCT ID: |
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NCT01186185 |
| Primary Contact: |
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Principal Investigator
Anh Nguyen-Huynh, MD PhD
Oregon Health and Science University
Anh Nguyen-Huynh, MD PhD
Phone: 503-494-8135
Email: nguyanh@ohsu.edu
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| Backup Contact: |
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Email: shib@ohsu.edu
Yong-Bing Shi, MD PhD
Phone: 503-494-7954
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| Location Contact: |
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Portland, Oregon 97239
United States
Anh Nguyen-Huynh
Phone: 503-260-9192
Email: nguyanh@ohsu.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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