Hearing loss pill shows promise in early trial
NCT ID NCT01444846
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether an oral drug called SPI-1005 could prevent temporary hearing changes caused by listening to loud music through headphones. 83 healthy adults took either the drug or a placebo for 4 days. The drug works by helping the body get rid of harmful chemicals produced by loud sounds.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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83 people
The number who actually took part.
- Start date
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Sep 2011
- Finished
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Mar 2014
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 31 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Healthy subjects at the time of enrollment. * Each subject will give informed consent to participate in this study and agrees to the treatment protocol. * Each subject will be interviewed regarding hearing and health to reveal any history of hearing loss, tinnitus, known ear pathology, use of any potentially ototoxic medications (i.e. diuretics, minocycline). * Non-occupational sound exposure (e.g., concerts, firearms, fireworks, power tools) will be avoided during the 24-hour period preceding baseline testing and throughout the duration of the study. * Subjects will have vital signs (i.e., heart rate, blood pressure, respirations, temperature) within normal limits upon medical examination. * Subjects must have normal audiologic assessment at baseline consisting of: * Baseline audiometric evaluation confirms that subjects have symmetric hearing with air conduction thresholds no worse than 25 decibels of Hearing Loss (dBHL) at frequencies between 0.25 to 8 kilo Hertz (kHz) bilaterally. * No significant threshold asymmetry (i.e. greater than 15 dB) between the ears at any tested frequency. * No significant air-bone gaps (i.e. greater than 10 dB) * Type A tympanograms bilaterally, defined as a range of -140 to +40 dekaPascals (daPa) based on the 90% range for adults (Margolis and Hunter 2000) Exclusion Criteria: * • Subjects with abnormal hearing levels \> 25 dBHL at any tested frequency (250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz) for either ear. * Exposure to any duration of non-occupational high-level sound (e.g., concerts, firearms, fireworks, power tools) during the 24 hour period preceding baseline audiometric testing as revealed in the subject questionnaire or during the medical examination. * Pathology of the external ear discovered upon otoscopic examination. * Pathology of the middle ear revealed by otoscopic examination, abnormal tympanometry, or reported history of middle ear problems. * Pathology of the inner ear or auditory nerve as revealed by reported history. * Subject complaints of aural pain, pressure, fullness, or drainage. * Subjects testing positive for pregnancy will be excluded from the study. * Subjects with other medical/health issues that would preclude voluntary participation in a drug study may be excluded at the discretion of the Principal Investigator. * Subjects that have previously received any known potentially ototoxic medication. This includes, but is not limited to, high dose salicylates (\>2 g/day), platinum-based chemotherapeutics and aminoglycoside antibiotics, such as streptomycin, gentamicin,tobramycin, amikacin, neomycin, and netilmycin. * Subjects that are currently using of any potentially ototoxic medications (i.e. diuretics or minocycline). * Subjects that have received any investigational treatment (drug or device) in the six months prior to this study. * Subjects exhibiting or self-reporting shortness of breath, wheezing, coughing, or hemoptysis
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Florida
Gainesville, Florida, 32610, United States