Fludrocortisone for Sudden Hearing Loss
This study is currently recruiting participants.
Verified August 2011 by Oregon Health and Science University
Sponsor:
Oregon Health and Science University
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 19, 2010 | ||||||||
| Last Updated Date | August 19, 2011 | ||||||||
| Start Date ICMJE | August 2010 | ||||||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01186185 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Fludrocortisone for Sudden Hearing Loss | ||||||||
| Official Title ICMJE | Mineralocorticoid Treatment for Sudden Sensorineural Hearing Loss | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Hearing Loss, Sensorineural | ||||||||
| Intervention ICMJE | Drug: Fludrocortisone
Fludrocortisone 0.2 mg by mouth daily for 30 days |
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| Study Arm (s) | Experimental: Fludrocortisone
Intervention: Drug: Fludrocortisone |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||
| Estimated Completion Date | August 2012 | ||||||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 89 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01186185 | ||||||||
| Other Study ID Numbers ICMJE | IRB00006240 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Anh Nguyen-Huynh, Oregon Health and Science University | ||||||||
| Study Sponsor ICMJE | Oregon Health and Science University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Oregon Health and Science University | ||||||||
| Verification Date | August 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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