A Study Of The Effects Of PF-04958242 In Subjects With Age-Related Hearing Loss

Hearing Loss, Sensorineural Clinical Trial

Official title:

A Double-Blind, Randomized, Placebo-Controlled, Single-Dose, Crossover Study Of The Safety And Efficacy Of Two Fixed Doses Of PF-04958242 In Subjects With Age-Related Sensorineural Hearing Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01518920
• Other study ID #: B1701005
• Status: Completed
• Phase: Phase 1
• Start date: December 2011
• Est. completion date: February 2013

Study information

• Verified date: November 2019
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

Drug:
• PF-04958242
PF-04958242 0.35 mg oral solution
• PF-04958242
PF-04958242 0.27 mg oral solution
• Placebo
Placebo oral solution

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Anaheim	California
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	New Haven	Connecticut
United States	Pfizer Investigational Site	New Haven	Connecticut
United States	Pfizer Investigational Site	New Haven	Connecticut
United States	Pfizer Investigational Site	New Haven	Connecticut
United States	Pfizer Investigational Site	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to 1 hour post-dose in pure tone audiometry averaged over 2 and 4 kHz		1 hour
Secondary	Change from baseline to 5 hours post-dose in pure tone audiometry averaged over 2 and 4 kHz		5 hours
Secondary	Change from baseline to 1 hr and 5 hrs post-dose in Speech Discrimination Score		1 hour, 5 hours
Secondary	Change from baseline to 1 hr and 5 hrs post dose in Speech In Noise Testing		1 hour, 5 hours
Secondary	Change from baseline to 1 hr and 5 hrs post dose in Tinnitus Severity Ranking Scale		1 hour, 5 hours
Secondary	Plasma PF 04958242 concentrations at 45 min post dose and following endpoint assessments at 1 and 5 hrs post dose.		45 min, 1 hour, 5 hours

External Links

•   To obtain contact information for a study center near you, click here.