Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.
SPI-1005 for Prevention and Treatment of Aminoglycoside Induced Ototoxicity
The primary objective of this study is to determine the safety and tolerability of SPI-1005
treatment in CF patients with active pulmonary exacerbation that are receiving an IV course
of tobramycin, using histories, physical exams, vital signs (VS), adverse event (AE)
reporting, hematology (CBC) chemistry (Chem-20).
The secondary objectives of this study are to determine the pharmacokinetics of oral SPI-1005
at 200, 400 and 600 mg BID for 21 days. Peak/trough assessments will be determined for
ebselen, its major metabolite and selenium. Clinical assessments of the severity of
sensorineural hearing loss, speech discrimination, vertigo severity, tinnitus severity and
lung function will be made compared between treatment arms and the placebo arm of this study.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Raksha Jain
19733
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT02819856
STU 052017-042
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Inclusion Criteria:
• Cystic fibrosis patients about to receive IV tobramycin for acute pulmonary
exacerbation.
• Voluntarily consent to participate in the study.
• Females of childbearing potential should be using and committed to continue using one
of the following acceptable birth control methods:
• Sexual abstinence (inactivity) for 14 days prior to screening through study
completion; or IUD in place for at least 3 months prior to study through study
completion; or Barrier method (condom or diaphragm) with spermicide for at least 14
days prior to screening through study completion; or Stable hormonal contraceptive for
at least 3 months prior to study through study completion.
• Ability to perform all behavioral tests as indicated.
Exclusion Criteria:
• Current use or within 60 days prior to study enrollment the following IV ototoxic
medications: aminoglycoside antibiotics (gentamicin, tobramycin, amikacin,
streptomycin); platinum-containing chemotherapies (cisplatin, carboplatin,
oxaliplatin); or loop diuretic (furosemide).
• History of idiopathic sensorineural hearing loss, otosclerosis, or vestibular
schwannoma.
• History of middle ear or inner ear surgery.
• Current conductive hearing loss or middle ear effusion.
• Significant cardiovascular, hepatic, renal, hematologic, endocrine, immunologic, or
psychiatric disease.
• History of hypersensitivity or idiosyncratic reaction to compounds related to ebselen.
• Participation in another investigational drug or device study within 30 days prior to
study enrollment.
• Female patients who are pregnant or breastfeeding.