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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

FX-322 in Adults With Age-Related Sensorineural Hearing Loss

NCT04601909

Presbycusis Hearing Loss, Sensorineural Noise Induced Hearing Loss +1 more

COMPLETED PHASE1

FX-322 in Adults With Severe Sensorineural Hearing Loss

NCT04629664

Hearing Loss, Sensorineural Noise Induced Hearing Loss Sudden Hearing Loss

COMPLETED PHASE1

FX-322 in Sensorineural Hearing Loss

NCT03616223

Sensorineural Hearing Loss

COMPLETED PHASE1/PHASE2

FX-322 in Adults With Stable Sensorineural Hearing Loss

NCT04120116

Sensorineural Hearing Loss Noise Induced Hearing Loss Sudden Sensorineural Hearing Loss

COMPLETED PHASE2

FX-322 in Adults With Acquired Sensorineural Hearing Loss

NCT05086276

Hearing Loss, Sensorineural Noise Induced Hearing Loss Sudden Hearing Loss

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hearing Loss, Sensorineural

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PF-04958242

Group Type EXPERIMENTAL

PF-04958242

Intervention Type DRUG

PF-04958242 0.27 mg oral solution

Intervention Type DRUG

Placebo

Placebo oral solution

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No