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A Study Of The Effects Of PF-04958242 In Subjects With Age-Related Hearing Loss
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01518920
First received: January 23, 2012
Last updated: April 1, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Hearing Loss, Sensorineural | Drug: PF-04958242 Drug: Placebo | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
nonsyndromic hearing loss
MedlinePlus related topics:
Hearing Disorders and Deafness
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Change from baseline to 1 hour post-dose in pure tone audiometry averaged over 2 and 4 kHz [ Time Frame: 1 hour ]
Secondary Outcome Measures:
- Change from baseline to 5 hours post-dose in pure tone audiometry averaged over 2 and 4 kHz [ Time Frame: 5 hours ]
- Change from baseline to 1 hr and 5 hrs post-dose in Speech Discrimination Score [ Time Frame: 1 hour, 5 hours ]
- Change from baseline to 1 hr and 5 hrs post dose in Speech In Noise Testing [ Time Frame: 1 hour, 5 hours ]
- Change from baseline to 1 hr and 5 hrs post dose in Tinnitus Severity Ranking Scale [ Time Frame: 1 hour, 5 hours ]
- 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 ]
| Enrollment: | 44 |
| Study Start Date: | December 2011 |
| Study Completion Date: | February 2013 |
| Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PF-04958242 |
Drug: PF-04958242
PF-04958242 0.35 mg oral solution
Drug: PF-04958242
PF-04958242 0.27 mg oral solution
|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo oral solution
|
Eligibility| Ages Eligible for Study: | 50 Years to 75 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01518920
Please refer to this study by its ClinicalTrials.gov identifier: NCT01518920
Locations
| United States, California | |
| Pfizer Investigational Site | |
| Anaheim, California, United States, 92801 | |
| United States, Connecticut | |
| Pfizer Investigational Site | |
| New Haven, Connecticut, United States, 06510 | |
| Pfizer Investigational Site | |
| New Haven, Connecticut, United States, 06511 | |
| Pfizer Investigational Site | |
| New Haven, Connecticut, United States, 06519 | |
| Pfizer Investigational Site | |
| New Haven, Connecticut, United States, 06520-8071 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| South Miami, Florida, United States, 33143 | |
| United States, Maryland | |
| Pfizer Investigational Site | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75390-8575 | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75390-8868 | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75390-8891 | |
| Pfizer Investigational Site | |
| Dallas, Texas, United States, 75390-9035 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01518920 History of Changes |
| Other Study ID Numbers: |
B1701005 |
| Study First Received: | January 23, 2012 |
| Last Updated: | April 1, 2013 |
Keywords provided by Pfizer:
|
Age related sensorineural hearing loss PF-04958242 |
Additional relevant MeSH terms:
|
Hearing Loss Deafness Hearing Loss, Sensorineural Hearing Disorders Ear Diseases |
Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on August 22, 2017