Status:
COMPLETED
Vestipitant Or Vestipitant/Paroxetine Combination In Subjects With Tinnitus And Hearing Loss.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Tinnitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Tinnitus associated to hearing loss is a high prevalent audiologic disorder with important unmet needs as far as therapy is concerned. The present study is exploring the possible beneficial effects on...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male or female subjects with a diagnosed tinnitus.
- Subject with THI severity grade of 3 or 4.
- Subjects willing to restrict alcohol intake.
- The subject must have given written consent.
- Women of childbearing potential who abstain from intercourse OR agree to birth control.
- Women of non-childbearing potential.
- Exclusion criteria:
- Subject with THI severity grade = 5 or less than or equal to 2.
- Subject with pathologic level of anxiety or depression.
- Subject with no audiogram deficit and with normal hearing.
- Subjects that do not respond to the lidocaine infusion test or show a large variability in pre-infusion values.
- Subjects with any serious medical or surgical condition
- Subjects positive for drug use and/or a history of substance abuse or dependence.
- Subjects who have taken psychotropic drugs or antidepressants within specified time frames.
- Subjects who have recently used an investigational drug or recently participated in a trial.
- Subjects who have exhibited intolerance to NK1 antagonists or SSRIs.
- Women who have a positive pregnancy test.
- Female subjects who intend to get pregnant or male subjects who intend to father a child within the next 4 weeks following the last study drug administration in the study.
- Subjects, who have donated a unit of blood or more within the previous month or who intend to donate blood within one month of completing the study.
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00394056
Start Date
December 1 2006
End Date
August 1 2009
Last Update
October 28 2016
Active Locations (1)
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1
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 2GG