Sudden Deafness Treatment Trial - Full Text View

Sponsored by:	National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by:	National Institute on Deafness and Other Communication Disorders (NIDCD)
ClinicalTrials.gov Identifier:	NCT00097448

Purpose

This trial aims to compare the efficacy of oral prednisone vs. methylprednisolone injected into the middle ear for the treatment of moderate-to-severe, sudden sensorineural hearing loss (inner ear hearing loss affecting one ear that occurs over less than 72 hours).

Condition	Intervention	Phase
Sudden Deafness	Drug: prednisone Drug: methylprednisolone sodium succinate	Phase III

Genetics Home Reference related topics: nonsyndromic deafness

MedlinePlus related topics: Hearing Disorders and Deafness

Drug Information available for: Methylprednisolone Methylprednisolone Sodium Succinate Prednisone Succinic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Sudden Hearing Loss Multicenter Treatment Trial

Further study details as provided by National Institute on Deafness and Other Communication Disorders (NIDCD):

Primary Outcome Measures:

hearing improvement [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	254
Study Start Date:	December 2004
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Nineteen days of oral prednisone	Drug: prednisone Oral, 19 days
2: Experimental Four doses of methylprednisolone sodium succinate delivered by injection to the middle ear over 2 weeks	Drug: methylprednisolone sodium succinate Four intratympanic injections delivered to the middle ear over 2 weeks

Detailed Description:

Sudden deafness is believed to affect 1:5000 people yearly. The cause is unknown. Spontaneous improvement is seen in approximately 20% of subjects. Improvement is seen in approximately 60% of subjects treated promptly with oral corticosteroids. Anecdotal case reports and uncontrolled case series have suggested the intratympanic corticosteroids may work as well or better than oral treatment. The risks of oral prednisone are well-known. In theory, intratympanic treatment should achieve a higher drug concentration at the target (inner ear) with less risk of systemic side effects. This study is a head-to-head comparison of oral prednisone vs. intratympanic methylprednisolone for primary treatment of idiopathic sudden deafness. The study is designed as a non-inferiority trial testing that hypothesis that intratympanic methylprednisolone is not inferior to oral prednisone treatment. Subjects assigned to the oral treatment arm receive 14 days of high dose prednisone (60mg/day) followed by a 5-day taper. Subjects assigned to the intratympanic treatment arm receive 4 doses of methylprednisolone injected into the middle twice weekly for two weeks. The primary outcome measure is hearing as measured by pure tone audiometry. Secondary outcomes include word recognition hearing levels and safety issues of local vs. systemic steroid side-effects and pain.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men/women 18 years and older in good health
Unilateral sensorineural hearing loss developing within 72 hours (SSNHL)
Pure Tone Average (PTA) (500, 1000, 2000, 4000 Hz) >/= 50 dB in the affected ear, with the affected ear >/= 30 dB worse than contralateral ear in at least one of the four frequencies
Symmetric hearing prior to onset of SSNHL
Hearing loss must be idiopathic
Hearing loss must have occurred within the past 14 days
Must be able to read or write English or Spanish

Exclusion Criteria:

SYSTEMIC DISEASE

>21 days prior oral steroid treatment within preceding 30 days
History of tuberculosis (TB) or positive PPD
Insulin-dependent diabetes mellitus
History of rheumatic disease, e.g., rheumatoid arthritis, scleroderma, lupus, etc.
Serious psychiatric disease or psychiatric reaction to corticosteroids
History of heart disease or transient ischemic attacks (TIAs)
Prior treatment with chemotherapeutic or immunosuppressive drugs
Pancreatitis
Active peptic ulcer disease or history of gastrointestinal bleeding
History of HIV, Hepatitis B or C
Chronic kidney failure
Alcohol abuse
Active shingles
Severe osteoporosis or non-surgical aseptic necrosis of the hip

OTOLOGIC DISEASE

Prior history of SSNHL
History of fluctuating hearing loss
History of Meniere's disease
History of chronic ear infection
History of otosclerosis
History of ear surgery (except childhood pressure equalization [pe] tubes)
History of congenital hearing loss
History of trauma immediately preceding onset of SSNHL
History of syphilitic hearing loss
History of genetic/hereditary hearing loss
Skull, facial, or temporal bone anomalies

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097448

Locations

United States, California
University of California San Diego	Recruiting
San Diego, California, United States, 92103-8895
Contact: Sharon Lindebak, MN, PA-C 858-657-6836 slindebak@ucsd.edu
Principal Investigator: Jeffrey P. Harris, MD, PhD
House Ear Institute	Recruiting
Los Angeles, California, United States, 90057
Contact: Roberta Leyvas 213-273-8025 rleyvas@hei.org
Principal Investigator: William H Slattery, III, MD
United States, Florida
University of Florida, College of Medicine	Recruiting
Gainesville, Florida, United States, 32610
Contact: Carrie R Reed 352-273-5171 carrie.reed@ent.ufl.edu
Principal Investigator: Patrick J Antonelli, MD
United States, Iowa
University of Iowa	Recruiting
Iowa City, Iowa, United States, 52242-1078
Contact: Deborah Strike, BSN, RN 319-356-3345 deborah-strike@uiowa.edu
Principal Investigator: Bruce J. Gantz, MD
Sub-Investigator: Marlan R. Hansen, MD
United States, Maryland
Johns Hopkins University	Recruiting
Baltimore, Maryland, United States, 21287-0910
Contact: Nancy Smith, PA-C 866-240-2576 nsmith2@jhmi.edu
Principal Investigator: John P. Carey, MD
Sub-Investigator: Charles Della Santina, MD, PhD
United States, Massachusetts
Massachusetts Eye & Ear Infirmary	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Mary L. Bartley, RN, BA 866-573-3628 mary_bartley@meei.harvard.edu
Principal Investigator: Steven D. Rauch, MD
Sub-Investigator: Daniel J. Lee, MD
University of Massachusetts Medical School	Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Karen Longtine, BS, RN, CCRC 508-722-0546 Karen.Longtine@umassmed.edu
Principal Investigator: Richard Gacek, MD
United States, Michigan
University of Michigan	Recruiting
Ann Arbor, Michigan, United States, 48109-0312
Contact: Laura Eldred 734-764-6106 leldred@umich.edu
Principal Investigator: Steven A. Telian, MD
Sub-Investigator: Hussam El-Kashlan, MD
Michigan Ear Institute	Recruiting
Farmington Hills, Michigan, United States, 48334
Contact: Cathy Bathurst, RN 248-865-4135 cbathurst53@yahoo.com
Principal Investigator: Seilesh Babu, MD
United States, Missouri
Washington University School of Medicine	Recruiting
St. Louis, Missouri, United States, 63110
Contact: Belinda Sinks, MA 314-362-7546 sinksb@ent-wustl.edu
Principal Investigator: Joel A Goebel, MD
United States, New York
New York University School of Medicine	Recruiting
New York, New York, United States, 10016
Contact: Dorline Jean, RN 212-263-7488 D.Jean@med.nyu.edu
Principal Investigator: Paul E. Hammerschlag, MD
Sub-Investigator: J. Thomas Roland, MD
New York Eye and Ear Infirmary	Recruiting
New York, New York, United States, 10003
Contact: Nina Suslina, BS 212-979-4082 nsuslina@nyee.edu
Contact: Glorimel Casambre, BS 212-353-5776 gcasambre@nyee.edu
Principal Investigator: Christopher Linstrom, MD
Sub-Investigator: George Alexiades, MD
Sub-Investigator: Ana Kim, MD
United States, Ohio
The Cleveland Clinic	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Michelle A. Crespo, RN, BSN 216-444-5029 crespom@ccf.org
Principal Investigator: Gordon B. Hughes, MD
Sub-Investigator: Peter C. Weber, MD
United States, Texas
University of Texas Southwestern Medical Center	Recruiting
Dallas, Texas, United States, 75390
Contact: Barbara Staves 214-648-9793 Barbara.staves@utsouthwestern.edu
Principal Investigator: Brandon Isaacson, MD
Baylor College of Medicine	Recruiting
Houston, Texas, United States, 77030
Contact: Sharon Congdon 713-798-5819 scongdon@bcm.tmc.edu
Principal Investigator: Jeffrey T Vrabec, MD
Canada, Ontario
London Health Sciences Center-University Hospital, University of Western Ontario	Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Francie Si 519-685-8500 ext 55415 francie.si@lhsc.on.ca
Principal Investigator: Lorne S Parnes, MD
Sub-Investigator: Duncan L MacRae, MD

Sponsors and Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

Principal Investigator:

Steven Rauch, MD

Massachusetts Eye and Ear Infirmary

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Massachusetts Eye and Ear Infirmary ( Steve D. Rauch, MD, Principal Investigator )
Study ID Numbers:	DC006296, 03-11-055
Study First Received:	November 23, 2004
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00097448
Health Authority:	United States: Federal Government; United States: Food and Drug Administration

Keywords provided by National Institute on Deafness and Other Communication Disorders (NIDCD):

sudden hearing loss
unilateral sudden sensorineural hearing loss
sudden sensorineural hearing loss
sudden unilateral hearing loss

Study placed in the following topic categories:

Sensation Disorders
Prednisone
Otorhinolaryngologic Diseases
Methylprednisolone
Hearing Loss, Sudden
Sensorineural hearing loss
Methylprednisolone acetate
Prednisolone acetate
Hearing Loss, Sensorineural

Hearing Loss, Unilateral
Ear Diseases
Signs and Symptoms
Deafness
Hearing Disorders
Prednisolone
Neurologic Manifestations
Hearing Loss
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Nervous System Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Antiemetics
Hormones

Neuroprotective Agents
Protective Agents
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009