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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Hearing Loss, Sensorineural	Drug: PF-04958242; Drug: Placebo	Phase 1

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	44 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Triple (Participant, 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
Study Start Date :	December 2011
Actual Primary Completion Date :	February 2013
Actual Study Completion Date :	February 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Change from baseline to 1 hour post-dose in pure tone audiometry averaged over 2 and 4 kHz [ Time Frame: 1 hour ]

Secondary Outcome Measures :

1. Change from baseline to 5 hours post-dose in pure tone audiometry averaged over 2 and 4 kHz [ Time Frame: 5 hours ]
2. Change from baseline to 1 hr and 5 hrs post-dose in Speech Discrimination Score [ Time Frame: 1 hour, 5 hours ]
3. Change from baseline to 1 hr and 5 hrs post dose in Speech In Noise Testing [ Time Frame: 1 hour, 5 hours ]
4. Change from baseline to 1 hr and 5 hrs post dose in Tinnitus Severity Ranking Scale [ Time Frame: 1 hour, 5 hours ]
5. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	50 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

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

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
First Posted:	January 26, 2012
Last Update Posted:	April 4, 2013
Last Verified:	April 2013

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