A Study Of The Effects Of PF-04958242 In Subjects With Age-Related Hearing Loss
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| ClinicalTrials.gov Identifier: NCT01518920 |
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Recruitment Status :
Completed
First Posted : January 26, 2012
Last Update Posted : April 4, 2013
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hearing Loss, Sensorineural | Drug: PF-04958242 Drug: Placebo | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 44 participants |
| 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 |
| Study Start Date : | December 2011 |
| Actual Primary Completion Date : | February 2013 |
| Actual Study Completion Date : | February 2013 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Hearing Disorders and Deafness
| Arm | Intervention/treatment |
|---|---|
| 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 |
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 ]
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| Ages Eligible for Study: | 50 Years to 75 Years (Adult, Older Adult) |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
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 |
| First Posted: | January 26, 2012 Key Record Dates |
| Last Update Posted: | April 4, 2013 |
| Last Verified: | April 2013 |
Keywords provided by Pfizer:
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Age related sensorineural hearing loss PF-04958242 |
Additional relevant MeSH terms:
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Hearing Loss Deafness Hearing Loss, Sensorineural Hearing Disorders Ear Diseases |
Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms |