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Sponsored by: |
National Institute on Deafness and Other Communication Disorders (NIDCD) |
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Information provided by: | National Institute on Deafness and Other Communication Disorders (NIDCD) |
ClinicalTrials.gov Identifier: | NCT00097448 |
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 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | Sudden Hearing Loss Multicenter Treatment Trial |
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
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
SYSTEMIC DISEASE
OTOLOGIC DISEASE
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 |
Principal Investigator: | Steven Rauch, MD | Massachusetts Eye and Ear Infirmary |
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 History of Changes |
Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
sudden hearing loss unilateral sudden sensorineural hearing loss sudden sensorineural hearing loss sudden unilateral hearing loss |
Anti-Inflammatory Agents Prednisone Sensation Disorders Methylprednisolone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Prednisolone acetate Sensorineural Hearing Loss Hearing Loss, Sensorineural Hearing Loss, Unilateral Ear Diseases Neuroprotective Agents Hormones |
Signs and Symptoms Hearing Disorders Deafness Hearing Loss Methylprednisolone Hemisuccinate Otorhinolaryngologic Diseases Antineoplastic Agents, Hormonal Hearing Loss, Sudden Methylprednisolone acetate Glucocorticoids Prednisolone Neurologic Manifestations Peripheral Nervous System Agents |
Anti-Inflammatory Agents Sensation Disorders Prednisone Antineoplastic Agents Methylprednisolone Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Prednisolone acetate Hormones Neuroprotective Agents Ear Diseases Signs and Symptoms Hearing Disorders Deafness |
Therapeutic Uses Hearing Loss Methylprednisolone Hemisuccinate Otorhinolaryngologic Diseases Antineoplastic Agents, Hormonal Hearing Loss, Sudden Nervous System Diseases Gastrointestinal Agents Methylprednisolone acetate Glucocorticoids Protective Agents Pharmacologic Actions Autonomic Agents Prednisolone Neurologic Manifestations |