Clinical trial NCT04917315: To Evaluate the Efficacy and Safety of JLP-2002 on Symptoms of Overactive Bladder
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Bridge Study to Evaluate the Efficacy and Safety of JLP-2002 in Patients With Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder
Lead sponsor: Jeil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-06-08
Enrollment: 210
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 associated with frequency and nocturia. The main drug class used is antimuscarinics, and the clinical utility of antimuscarinic drugs is limited due to its mild efficacy and poor tolerability due to side effects of mechanisms such as dry mouth and constipation. In addition to poor tolerability and mild efficacy, recent literature suggests that long-term use of anticholinergics is associated with cognitive impairment and dementia. Therefore, the purpose of this study was to evaluate the treatment effect of overactive bladder symptoms through the change in the average number of urination per day after administration of JLP-2002, a beta 3-adrenergic receptor (β3-AR) agonist with an effective alternative mechanism, for 12 weeks.


Eligibility 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:

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 with a history of allergy to β-adrenergic receptor agonists, intolerant or clinically significant adverse events, or abnormal clinical laboratory values
5. Pregnant or lactating women
6. 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
7. Those who received other investigational products or investigational devices within 30 days before screening
8. Those who are determined by the investigator to be not eligible for this study due to clinically significant abnormal findings of screening tests

Primary outcomes:
measure: Change From Baseline in Average Daily Micturitions at Week 12
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References: