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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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:
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
- Change from baseline to 1 hr and 5 hrs post-dose in Speech Discrimination Score [ Time Frame: 1 hour, 5 hours ] [ Designated as safety issue: No ]
- Change from baseline to 1 hr and 5 hrs post dose in Speech In Noise Testing [ Time Frame: 1 hour, 5 hours ] [ Designated as safety issue: No ]
- Change from baseline to 1 hr and 5 hrs post dose in Tinnitus Severity Ranking Scale [ Time Frame: 1 hour, 5 hours ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| 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 |
| Genders Eligible for Study: | Both |
| 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
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, 75390-9035 | |
| 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 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| 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 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Age related sensorineural hearing loss PF-04958242 |
Additional relevant MeSH terms:
|
Hearing Loss Deafness Hearing Loss, Sensorineural Presbycusis Hearing Disorders Ear Diseases |
Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013