To Evaluate the Efficacy and Safety of JLP-2002 on Symptoms of Overactive Bladder

NCT ID: NCT04917315

Last Updated: 2022-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-21
• Study Completion Date: 2021-08-18

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.

Conditions

Overactive Bladder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

JLP-2002

Drug: JLP-2002

Group Type: EXPERIMENTAL

JLP-2002 A mg

Intervention Type: DRUG

administration of JLP-2002 Participants received one vibegron A mg tablet, taken orally each morning, for 12 weeks.

Placebo

Drug: Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

administration of Placebo Participants received one placebo tablet, taken orally each morning, for 12 weeks.

Interventions

JLP-2002 A mg

administration of JLP-2002 Participants received one vibegron A mg tablet, taken orally each morning, for 12 weeks.

Intervention Type: DRUG

Placebo

administration of Placebo Participants received one placebo tablet, taken orally each morning, for 12 weeks.

Intervention Type: DRUG

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jeil Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

JLP-2002-301

Identifier Type: -

Identifier Source: org_study_id