Status:
COMPLETED
A Study Of The Effects Of PF-04958242 In Subjects With Age-Related Hearing Loss
Lead Sponsor:
Biogen
Conditions:
Hearing Loss, Sensorineural
Eligibility:
All Genders
50-75 years
Phase:
PHASE1
Brief Summary
The objective of this study is to examine the safety, tolerability, and effects on hearing thresholds of two single doses of PF-04958242 and placebo in subjects with age-related hearing loss.
Detailed Description
This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.
Eligibility Criteria
Inclusion
- Subjects must have a current diagnosis of age related sensorineural hearing loss in the range of 30-60 dB, averaged over 2 and 4 kHz in at least one ear.
- Subjects must have symmetric hearing loss
- Subjects who can read, speak and comprehend English.
Exclusion
- Subjects who have a history of sudden hearing loss and history or diagnosis of rapidly progressive idiopathic hearing loss
- Subjects who have hearing disorders other than age related sensorineural hearing loss
- Subjects with moderate or greater tinnitus
- Pregnant females; breastfeeding females; females of childbearing potential
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01518920
Start Date
December 1 2011
End Date
February 1 2013
Last Update
November 21 2019
Active Locations (11)
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1
Pfizer Investigational Site
Anaheim, California, United States, 92801
2
Pfizer Investigational Site
New Haven, Connecticut, United States, 06510
3
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
4
Pfizer Investigational Site
New Haven, Connecticut, United States, 06519