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

Purpose

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.

Condition	Intervention	Phase
Hearing Loss, Sensorineural	Drug: PF-04958242 Drug: Placebo	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: nonsyndromic hearing loss

MedlinePlus related topics: Hearing Disorders and Deafness

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change from baseline to 1 hour post-dose in pure tone audiometry averaged over 2 and 4 kHz [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline to 5 hours post-dose in pure tone audiometry averaged over 2 and 4 kHz [ Time Frame: 5 hours ] [ Designated as safety issue: No ]
Change from baseline to 1 hr and 5 hrs post-dose in Speech Discrimination Score [ Time Frame: 1 hour, 5 hours ] [ Designated as safety issue: No ]
Change from baseline to 1 hr and 5 hrs post dose in Speech In Noise Testing [ Time Frame: 1 hour, 5 hours ] [ Designated as safety issue: No ]
Change from baseline to 1 hr and 5 hrs post dose in Tinnitus Severity Ranking Scale [ Time Frame: 1 hour, 5 hours ] [ Designated as safety issue: No ]
Plasma PF 04958242 concentrations at 45 min post dose and following endpoint assessments at 1 and 5 hrs post dose. [ Time Frame: 45 min, 1 hour, 5 hours ] [ Designated as safety issue: No ]


Enrollment:	44
Study Start Date:	December 2011
Study Completion Date:	February 2013
Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: PF-04958242	Drug: PF-04958242 PF-04958242 0.35 mg oral solution Drug: PF-04958242 PF-04958242 0.27 mg oral solution
Placebo Comparator: Placebo	Drug: Placebo Placebo oral solution

Eligibility


Ages Eligible for Study:	50 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01518920

Locations


United States, California
Pfizer Investigational Site
Anaheim, California, United States, 92801
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06510
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Pfizer Investigational Site
New Haven, Connecticut, United States, 06519
Pfizer Investigational Site
New Haven, Connecticut, United States, 06520-8071
United States, Florida
Pfizer Investigational Site
South Miami, Florida, United States, 33143
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21287
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75390-8575
Pfizer Investigational Site
Dallas, Texas, United States, 75390-8868
Pfizer Investigational Site
Dallas, Texas, United States, 75390-8891
Pfizer Investigational Site
Dallas, Texas, United States, 75390-9035

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bednar MM, DeMartinis N, Banerjee A, Bowditch S, Gaudreault F, Zumpano L, Lin FR. The Safety and Efficacy of PF-04958242 in Age-Related Sensorineural Hearing Loss: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2015 Jul;141(7):607-13. doi: 10.1001/jamaoto.2015.0791.


Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01518920 History of Changes
Other Study ID Numbers:	B1701005
Study First Received:	January 23, 2012
Last Updated:	April 1, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:


Age related sensorineural hearing loss PF-04958242

Additional relevant MeSH terms:


Hearing Loss Deafness Hearing Loss, Sensorineural Hearing Disorders Ear Diseases	Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms

ClinicalTrials.gov processed this record on September 23, 2016