44
Participants
Start Date
March 31, 2010
Primary Completion Date
March 31, 2011
Study Completion Date
April 30, 2011
OTO-104 (steroid) 3 mg
OTO-104 3 mg dose cohort, single intratympanic injection.
Placebo
Placebo arm will be conducted in parallel with each OTO-104 dose cohort.
OTO-104 (steroid) 12 mg
Sequential dose cohort escalation to OTO-104 12 mg dose cohort will occur pending the safety evaluation of 28 day follow up safety data for the OTO-104 3 mg dose cohort. OTO-104 12mg dose cohort is also a single intratympanic injection.
New York Eye and Ear Infirmary, New York
Piedmont Medical Research, Winston-Salem
Crescent Medical Research, Salisbury
Wilmington Medical Research, Wilmington
Medical University of South Carolina, Charleston
Silverstein Institute, Sarasota
University of Michigan Hospitals, Dept. of Otolaryngology, Ann Arbor
Michigan Ear Institute, Farmington Hills
Northwestern University, Feinberg School of Medicine, Otolaryngology, Chicago
St Louis University, St Louis
University Of Texas, Southwestern Medical Center, Dallas
Colorado Otolaryngology Associates, Colorado Springs
House Ear Institute, Los Angeles
University of California, San Diego, San Diego
Mass Eye & Ear Infirmary, Boston
Lead Sponsor
Otonomy, Inc.
INDUSTRY