Status:
COMPLETED
To Evaluate the Efficacy and Safety of JLP-2002 on Symptoms of Overactive Bladder
Lead Sponsor:
Jeil Pharmaceutical Co., Ltd.
Conditions:
Overactive Bladder
Eligibility:
All Genders
19+ years
Phase:
PHASE3
Brief Summary
Overactive bladder (OAB) is a clinical condition characterized by urgency (i.e., urinary urinary urinary urgency that is difficult to delay and unbearable) with or without urge incontinence, usually a...
Eligibility Criteria
Inclusion
- 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
- Males or females aged 19 years or older at the time of written consent
- Those who have already experienced symptoms of overactive bladder (OAB)\* for 6 months or more at the time of screening
- Those who are able to read, understand, and write in a voiding diary and a questionnaire
- Those who are able to go to the toilet on foot without other's help
Exclusion
- Those who have a history of malignancies within 3 years before screening
- Those who were previously or are currently diagnosed with urinary malignancies (e.g., bladder cancer)
- 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
- Those with a history of allergy to β-adrenergic receptor agonists, intolerant or clinically significant adverse events, or abnormal clinical laboratory values
- Pregnant or lactating women
- 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
- Those who received other investigational products or investigational devices within 30 days before screening
- Those who are determined by the investigator to be not eligible for this study due to clinically significant abnormal findings of screening tests
Key Trial Info
Start Date :
May 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2021
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT04917315
Start Date
May 21 2020
End Date
August 18 2021
Last Update
January 28 2022
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea