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Phase II Study of KRP-209

Phase II Study of KRP-209 - A Clinical Trial to Evaluate Efficacy and Safety of KRP-209 in Patients with Subjective Tinnitus -

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221608
Enrollment
400
Registered
2011-10-05
Start date
2011-10-05
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subjective tinnitus

Interventions

Sponsors

Kyorin Pharmaceutical Co.,LTD
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
The amount of change from 0 weeks in the point of each evaluation. - Tinnitus handicap inventory(THI), etc. -

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026