NCT01518920

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 26, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

November 21, 2019

Status Verified

November 1, 2019

Enrollment Period

1.2 years

First QC Date

January 23, 2012

Last Update Submit

November 19, 2019

Conditions

Hearing Loss, Sensorineural

Keywords

Age related sensorineural hearing lossPF-04958242

Outcome Measures

Primary Outcomes (1)

  • Change from baseline to 1 hour post-dose in pure tone audiometry averaged over 2 and 4 kHz

    1 hour

Secondary Outcomes (5)

  • Change from baseline to 5 hours post-dose in pure tone audiometry averaged over 2 and 4 kHz

    5 hours

  • Change from baseline to 1 hr and 5 hrs post-dose in Speech Discrimination Score

    1 hour, 5 hours

  • Change from baseline to 1 hr and 5 hrs post dose in Speech In Noise Testing

    1 hour, 5 hours

  • Change from baseline to 1 hr and 5 hrs post dose in Tinnitus Severity Ranking Scale

    1 hour, 5 hours

  • Plasma PF 04958242 concentrations at 45 min post dose and following endpoint assessments at 1 and 5 hrs post dose.

    45 min, 1 hour, 5 hours

Study Arms (2)

PF-04958242

EXPERIMENTAL
Drug: PF-04958242

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PF-04958242DRUG

PF-04958242 0.35 mg oral solution

PF-04958242
PlaceboDRUG

Placebo oral solution

Placebo

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Pfizer Investigational Site

Anaheim, California, 92801, United States

Location

Pfizer Investigational Site

New Haven, Connecticut, 06510, United States

Location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Pfizer Investigational Site

New Haven, Connecticut, 06519, United States

Location

Pfizer Investigational Site

New Haven, Connecticut, 06520-8071, United States

Location

Pfizer Investigational Site

South Miami, Florida, 33143, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21287, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75390-8575, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75390-8868, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75390-8891, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75390-9035, United States

Location

Related Publications (1)

  • 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.

    PMID: 25997115DERIVED

Related Links

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Interventions

PF-04958242

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Medical Director

    Biogen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2012

First Posted

January 26, 2012

Study Start

December 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

November 21, 2019

Record last verified: 2019-11

Locations

US(11)