This is a randomized, double-blind study of PIPE-505, or placebo, in subjects with hearing loss associated with speech-in-noise impairment.
This is a randomized-controlled, double-blind study of PIPE-505 or placebo given as an injection one time in subjects with sensorineural hearing loss associated with speech-in-noise difficulty. Visits to the clinic will occur at baseline, dosing, and days 1, 7, 14, 30, 60 and 90 after treatment. Safety will be assessed by periodic measurement of vital signs, ear examination, electrocardiogram (ECG), blood laboratory analyses and occurrence of adverse events (AE). Efficacy will be assessed by periodic audiometry and other audiological tests.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
28
Breathe Clear Institute
Torrance, California, United States
ENT and Allergy Associates of Florida
Boca Raton, Florida, United States
Advanced ENT & Allergy
New Albany, Indiana, United States
University of Kansas; Dept of Otolaryngology Head & Neck Surgery
Safety: Treatment-Emergent Adverse Events (TEAE)
Number of participants with TEAEs
Time frame: From baseline to 3 months follow up
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Kansas City, Kansas, United States
Advanced ENT & Allergy
Louisville, Kentucky, United States
Charlotte Eye Ear Nose Throat Associates
Charlotte, North Carolina, United States
Piedmont Ear Nose Throat and Associates
Winston-Salem, North Carolina, United States
Chrysalis Clinical Research
St. George, Utah, United States