KRP-DT123 Pivotal Study

KRP-DT123 Pivotal Study - A Multicenter, randomized, double-blind, sham-controlled, parallel-group comparative study of KRP-DT123 in patients with tinnitus disorder -

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2032260125

Enrollment

210

Registered

2026-05-12

Start date

2026-06-15

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

Chronic Tinnitus

Interventions

Treatment Group: Use of treatment app for 16 weeks Control Group: Use of control app for 16 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Men or women aged at least 18 years and yonger than 75 years (2)Patients with clinically diagnosed chronic unilateral or bilateral tinnitus. (3)Duration of bothersome tinnitus symptoms at least 3 months but less than 4 years. (4)At least 28 days had elapsed since the patient's initial doctor's visit for tinnitus(eg, intake examination, diagnostic testing, educational counseling).

Exclusion criteria

Exclusion criteria: (1)Diagnosed with pulsatile or paroxysmal tinnitus. (2)Complicated by fluctuating hearing loss (e.g., Meniere's disease,low-frequency sensorineuralhearing loss), post-labyrinthine hearing loss (e.g., acoustic neuroma), glomus tumor, or arteriovenous malformation. (3)Comorbid with middle ear disease requiring treatment (e.g., otitis media, otosclerosis, eustachian tube dysfunction) or acute hearing loss. (4)Initiated hearing aid use within 6 months prior to registration (excluding cross hearing aids)

Design outcomes

Primary

Measure	Time frame
Change from baseline on week 16 in the Tinnitus Handicap Inventory (THI) score	—

Contacts

Public ContactKenichi Yashiro

KYORIN Pharmaceutical Co.,Ltd.

ml-kyorin_jrct@mb.kyorin-pharm.co.jp+81-3-6368-4834

Outcome results

None listed

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