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Otoprotection With SPI-1005 for Prevention of Temporary Auditory Threshold Shift

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ClinicalTrials.gov Identifier: NCT01444846
Recruitment Status : Completed
First Posted : October 3, 2011
Last Update Posted : August 28, 2014
Sponsor:
Collaborator:
University of Florida
Information provided by (Responsible Party):
Sound Pharmaceuticals, Incorporated

Tracking Information
First Submitted Date  ICMJE September 29, 2011
First Posted Date  ICMJE October 3, 2011
Last Update Posted Date August 28, 2014
Study Start Date  ICMJE September 2011
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2011)
Reduction in Temporary Threshold Shift [ Time Frame: 1 week ]
Post-sound exposure pure tone audiometry will be compared with baseline (i.e., immediately pre-sound exposure) testing to determine group mean level hearing threshold shift changes between treated and placebo groups.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01444846 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Otoprotection With SPI-1005 for Prevention of Temporary Auditory Threshold Shift
Official Title  ICMJE Phase 2 Study of the Safety and Efficacy of an Oral Formulation of SPI-1005 for Prevention of Temporary Auditory Threshold Shift
Brief Summary Exposure to loud sounds can cause hearing loss. The purpose of this research study is to evaluate potential prevention of temporary changes in hearing that may occur after listening to music through an iPod or personal music player. We will measure temporary changes in hearing in subjects who listen to music and take either the study drug, SPI-1005, or a placebo for 4 days. SPI-1005 is a proprietary preparation of ebselen that allows it to be taken by mouth. Ebselen contains the mineral selenium and behaves like Glutathione Peroxidase, an enzyme that helps to rid the body of damaging chemicals caused by loud sounds.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Temporary Auditory Threshold Shift
Intervention  ICMJE
  • Drug: SPI-1005 Low dose
    Oral capsules, 200 mg ebselen, twice daily, 4 days
    Other Name: 200 mg Ebselen
  • Drug: SPI-1005 Middle dose
    Oral capsules, 400 mg ebselen, twice daily, 4 days
    Other Name: 400 mg Ebselen
  • Drug: SPI-1005 High dose
    Oral capsules, 600 mg ebselen, twice daily, 4 days
    Other Name: 600mgEbselen
  • Drug: Placebo
    Oral capsules, 0 mg ebselen, twice daily, 4 days
    Other Name: 0 mg Ebselen
Study Arms  ICMJE
  • Active Comparator: SPI-1005 Low dose
    200mg SPI-1005, capsule, bid, po, x4d
    Intervention: Drug: SPI-1005 Low dose
  • Active Comparator: SPI-1005 Middle Dose
    400mg SPI-1005, capsule, bid, po, x4d
    Intervention: Drug: SPI-1005 Middle dose
  • Active Comparator: SPI-1005 High Dose
    600mg SPI-1005, capsule, bid, po, x4d
    Intervention: Drug: SPI-1005 High dose
  • Placebo Comparator: Placebo
    0mg SPI-1005, capsule, bid, po, x4d
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 26, 2014)
83
Original Estimated Enrollment  ICMJE
 (submitted: September 30, 2011)
80
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 31 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01444846
Other Study ID Numbers  ICMJE SPI-1005-202
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sound Pharmaceuticals, Incorporated
Study Sponsor  ICMJE Sound Pharmaceuticals, Incorporated
Collaborators  ICMJE University of Florida
Investigators  ICMJE
Principal Investigator: Colleen Le Prell, PhD University of Florida
Study Director: Jonathan Kil, MD Sound Pharmaceuticals, Inc
Study Director: Eric D Lynch, PhD Sound Pharmaceuticals, Inc
PRS Account Sound Pharmaceuticals, Incorporated
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP