Safety Study for NST-001 and the Neuroject Injection Set to Treat Tinnitus
NCT ID: NCT00957788
Last Updated: 2013-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
8 participants
INTERVENTIONAL
2009-01-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 0
NST-001
Comparison of different dosages of drug.
Cohort 1
NST-001
Comparison of different dosages of drug.
Cohort 2
NST-001
Comparison of different dosages of drug.
Cohort 3
NST-001
Comparison of different dosages of drug.
Interventions
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NST-001
Comparison of different dosages of drug.
Eligibility Criteria
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Inclusion Criteria
* Severe tinnitus in one ear that began no more than ten years ago.
* Ear to be treated must be deaf or have profound hearing loss.
* Subjects with cardiac disease or hypertension, must have stable disease for at least 6 months.
* Subject must have intact cochlear nerve on the ear to be treated.
* Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods as recommended by the study physician.
Exclusion Criteria
* Current diagnosis or history of pancreatitis.
* Females that are pregnant or lactating.
* Use of investigational drugs within the previous 30 days.
* History of drug dependency or other substance abuse.
18 Years
70 Years
ALL
No
Sponsors
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NeuroSystec Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Bruno Frachet, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital Avicenne
Pierre Garin, MD
Role: STUDY_DIRECTOR
Cliniques Universitaries U.C.L.
Locations
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Cliniques Universitaries U.C.L.
Mont-Godinne, , Belgium
Hôpital Avicenne
Bobigny, Cedex, France
Countries
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Other Identifiers
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NST-CP-02
Identifier Type: -
Identifier Source: org_study_id
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