Efficacy of SPI‐1005 for Prevention of Noise‐Induced Hearing Loss: Phase 2 Clinical Trial Results
| Autor: | Colleen G. Le Prell, Patrick J. Antonelli, Scott K. Griffiths, Jonathan Kil, Edward Lobarinas, Eric D. Lynch, Christopher Spankovich |
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| Rok vydání: | 2014 |
| Předmět: |
medicine.medical_specialty
medicine.diagnostic_test business.industry Hearing loss Incidence (epidemiology) Phases of clinical research Audiology medicine.disease Placebo Sound exposure Otorhinolaryngology medicine Surgery Pure tone audiometry medicine.symptom business Auditory fatigue Noise-induced hearing loss |
| Zdroj: | Otolaryngology–Head and Neck Surgery. 151 |
| ISSN: | 1097-6817 0194-5998 |
| Popis: | Objectives:Determine the safety and efficacy of SPI-1005, a novel oral glutathione peroxidase (GPx) mimic and inducer, in preventing and treating noise-induced hearing loss (NIHL) in adults ranging from slight hearing loss (≤25 dBHL) to normal hearing.Methods:Randomized double blind placebo controlled Phase 2 clinical trial conducted December 2012 through November 2013. A total of 83 subjects at the University of Florida were enrolled and treated with either placebo or SPI-1005 prior to a single iPod sound exposure lasting 4 hours that induced a slight temporary threshold shift (TTS). The incidence (≥10 dBHL), severity (dBHL), and duration (up to 1 week post sound) of the TTS were determined by serial pure tone audiometry. The intervention (200, 400, or 600 mg SPI-1005 twice daily × 4 days) was compared with matching placebo in reducing the TTS. Significance was determined by 2-tailed t tests comparing a specific SPI-1005 treatment group versus placebo.Results:Oral SPI-1005 treatment showed a significant ... |
| Databáze: | OpenAIRE |
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