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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01518920
First received: January 23, 2012
Last updated: April 1, 2013
Last verified: April 2013
  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:


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
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
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, 75390-9035
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
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

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
Presbycusis
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014