Phase II Study of KRP-209
Phase 2
- Conditions
- Subjective tinnitus
- Registration Number
- JPRN-jRCT2080221608
- Lead Sponsor
- Kyorin Pharmaceutical Co.,LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
Patients with a clinical diagnosis of first onset, persistent (i.e. tinnitus should never be absent for >24 hours in a row), subjective, uni- or bilateral tinnitus. In case of bilateral tinnitus this criterion applies to both ears.
Exclusion Criteria
- Clinical diagnosis of intermittent or pulsatile tinnitus.
- Patients who have tinnitus as a concomitant sympton of a middle ear disease(such as otitis media, otosclerosis, eustachian tube dysfunction, etc), fluctuant hearing impairment(such as Meniere's disease, etc), retrocochlear hearingloss(such as acoustic neuroma), arteriovenous malformation or glomus tumor.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The amount of change from 0 weeks in the point of each evaluation.<br>- Tinnitus handicap inventory(THI), etc.<br>-
- Secondary Outcome Measures
Name Time Method