To evaluate the efficacy and safety of JLP-2002 on symptoms of overactive bladder

A multicenter, randomized, double-blind, placebo-controlled, parallel, bridge study to evaluate the efficacy and safety of JLP-2002 in patients with overactive bladder

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0005651

Enrollment

210

Registered

2020-12-02

Start date

2020-09-24

Completion date

Unknown

Last updated

2021-01-06

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

Conditions

None listed

Interventions

Drug : Study group(JLP-2002 50mg), Control group (Placebo) Once in daily, PO, total 12 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Those who are fully informed of this study and then completely understand its contents, voluntarily decide to participate in this study, and give written consent to follow instructions 2) Males or females aged 19 years or older at the time of written consent 3) Those who have already experienced symptoms of overactive bladder (OAB)* for 6 months or more at the time of screening 4) Those who are able to read, understand, and write in a voiding diary and a questionnaire 5) Those who are able to go to the toilet on foot without other's help

Exclusion criteria

Exclusion criteria: 1) Those who have a history of malignancies within 3 years before screening 2) Those who were previously or are currently diagnosed with urinary malignancies (e.g., bladder cancer) 3) Males who were previously or are currently diagnosed with prostate cancer or whose prostate-specific antigen (PSA) level is = 4ng/mL within 1 year before screening or at screening 4) Those who are determined by the investigator to be not eligible for this study due to clinically significant abnormal findings of screening tests 5) Those whose systolic blood pressure (SBP) is =160mmHg; diastolic blood pressure (DBP) is =100 mmHg; or pulse is =110 bpm at the time of screening and randomization

Design outcomes

Primary

Measure	Time frame
daily frequency of voiding	—

Secondary

Measure	Time frame
daily frequency of urinary urgency	—

Countries

Korea, Republic of

Contacts

Public ContactMyung-soo Choo

Asan Medical Center

Outcome results