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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Anaheim, California, 92801 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Sensorineural Hearing Loss
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01518920
Pfizer
Completed
A Study Of The Effects Of PF-04958242 In Subjects With Age-Related Hearing Loss

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Similar Trials

Sensorineural Hearing Loss
NCT01518920
All Genders
50+
Years
Multiple Sites
A Study Of The Effects Of PF-04958242 In Subjects With Age-Related Hearing Loss
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hearing Loss, Sensorineural
  • Drug: PF-04958242
    PF-04958242 0.35 mg oral solution
  • Drug: PF-04958242
    PF-04958242 0.27 mg oral solution
  • Drug: Placebo
    Placebo oral solution
  • Experimental: PF-04958242
    Interventions:
    • Drug: PF-04958242
    • Drug: PF-04958242
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
February 2013
February 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01518920
B1701005
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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