Back to resultsA Study Of The Effects Of PF-04958242 In Subjects With Age-Related Hearing Loss
Primary Purpose
Hearing Loss, Sensorineural
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PF-04958242
PF-04958242
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss, Sensorineural focused on measuring Age related sensorineural hearing loss, PF-04958242
Eligibility 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
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
PF-04958242
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline to 1 hour post-dose in pure tone audiometry averaged over 2 and 4 kHz
Secondary Outcome Measures
Change from baseline to 5 hours post-dose in pure tone audiometry averaged over 2 and 4 kHz
Change from baseline to 1 hr and 5 hrs post-dose in Speech Discrimination Score
Change from baseline to 1 hr and 5 hrs post dose in Speech In Noise Testing
Change from baseline to 1 hr and 5 hrs post dose in Tinnitus Severity Ranking Scale
Plasma PF 04958242 concentrations at 45 min post dose and following endpoint assessments at 1 and 5 hrs post dose.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01518920
Brief Title
A Study Of The Effects Of PF-04958242 In Subjects With Age-Related Hearing Loss
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 Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural
Keywords
Age related sensorineural hearing loss, PF-04958242
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PF-04958242
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PF-04958242
Intervention Description
PF-04958242 0.35 mg oral solution
Intervention Type
Drug
Intervention Name(s)
PF-04958242
Intervention Description
PF-04958242 0.27 mg oral solution
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo oral solution
Primary Outcome Measure Information:
Title
Change from baseline to 1 hour post-dose in pure tone audiometry averaged over 2 and 4 kHz
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Change from baseline to 5 hours post-dose in pure tone audiometry averaged over 2 and 4 kHz
Time Frame
5 hours
Title
Change from baseline to 1 hr and 5 hrs post-dose in Speech Discrimination Score
Time Frame
1 hour, 5 hours
Title
Change from baseline to 1 hr and 5 hrs post dose in Speech In Noise Testing
Time Frame
1 hour, 5 hours
Title
Change from baseline to 1 hr and 5 hrs post dose in Tinnitus Severity Ranking Scale
Time Frame
1 hour, 5 hours
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Pfizer Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Pfizer Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Pfizer Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Pfizer Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8071
Country
United States
Facility Name
Pfizer Investigational Site
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Pfizer Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8575
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8868
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8891
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9035
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25997115
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1701005&StudyName=A%20Study%20Of%20The%20Effects%20Of%20PF-04958242%20In%20Subjects%20With%20Age-Related%20Hearing%20Loss
Description
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A Study Of The Effects Of PF-04958242 In Subjects With Age-Related Hearing Loss
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