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

Last updated on December 5, 2019

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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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Descriptive Information
Brief Title  ICMJE A Study Of The Effects Of PF-04958242 In Subjects With Age-Related Hearing Loss
Official Title  ICMJE 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
Brief SummaryThe 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 DescriptionThis study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hearing Loss, Sensorineural
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: PF-04958242
    Interventions:
    • Drug: PF-04958242
    • Drug: PF-04958242
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications *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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 1, 2013)
44
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2012)
42
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion DateFebruary 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01518920
Other Study ID Numbers  ICMJE B1701005
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyBiogen
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical DirectorBiogen
PRS AccountBiogen
Verification DateNovember 2019

ICMJE     Data element required by the

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

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