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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.
This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-04958242 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04958242 | Drug | PF-04958242 0.35 mg oral solution |
| |
| PF-04958242 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to 1 hour post-dose in pure tone audiometry averaged over 2 and 4 kHz | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Anaheim | California | 92801 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25997115 | Derived | 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. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Drug |
PF-04958242 0.27 mg oral solution |
|
| Placebo | Drug | Placebo oral solution |
|
| 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 |
| New Haven |
| Connecticut |
| 06510 |
| United States |
| Pfizer Investigational Site | New Haven | Connecticut | 06511 | United States |
| Pfizer Investigational Site | New Haven | Connecticut | 06519 | United States |
| Pfizer Investigational Site | New Haven | Connecticut | 06520-8071 | United States |
| Pfizer Investigational Site | South Miami | Florida | 33143 | United States |
| Pfizer Investigational Site | Baltimore | Maryland | 21287 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75390-8575 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75390-8868 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75390-8891 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75390-9035 | United States |
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000600968 | PF-04958242 |
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