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Phase III study of KRP-114V

A Phase III, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of The Beta-3 Agonist KRP-114V in Japanese Subjects With Symptoms of Overactive Bladder

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222884
Enrollment
1090
Registered
2015-06-17
Start date
2015-06-17
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

Overactive bladder(OAB)

Interventions

Sponsors

Kyorin Pharmaceutical Co.,LTD
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patient showing clear OAB symptoms

Exclusion criteria

Exclusion criteria: Patients complicated with urinary tract infection, urinary stones, and/or interstitial cystitis Patients with a previous history of recurrent urinary tract infection Patients confirmed to have a post-void residual volume of more than 100 mL

Design outcomes

Primary

MeasureTime frame
Efficacy ( The average number of micturitions per 1 day) Bladder diary

Secondary

MeasureTime frame
Efficacy (The average number of urgency per 1 day, etc.), Safety Bladder diary, Adverse event and adverse drug reaction

Outcome results

None listed

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