Fludrocortisone for Sudden Hearing Loss

NCT01186185 | Terminated Early Phase 1 FDA Drug

• 1 other identifier: IRB00006240
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss, Sensorineural

Keywords

sudden; sensorineural; hearing loss; fludrocortisone; mineralocorticoid; steroid

Outcome Measures

Primary Outcomes (1)

• Hearing

  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.

  At one month

Study Arms (1)

Fludrocortisone

EXPERIMENTAL

Drug: Fludrocortisone

Interventions

Fludrocortisone DRUG

Fludrocortisone 0.2 mg by mouth daily for 30 days

Fludrocortisone

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Idiopathic sudden sensorineural hearing loss within 3 months
• Failure to recover hearing with glucocorticoid treatment or inability to tolerate glucocorticoid

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Hearing Loss

Interventions

Fludrocortisone

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydrocortisone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Anh Nguyen-Huynh, MD PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2010
• First Posted: August 23, 2010
• Study Start: August 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: October 18, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)