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

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.

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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

Treatment and study plan

JLP-2002 A mg

Drug

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

Placebo

Drug

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

Primary outcomes

Change From Baseline in Average Daily Micturitions at Week 12

Time frame: Week 12

Participants were required to keep a voiding diary, recording the occurrence of each micturition. The average daily number of micturitions was calculated as the total number of micturitions that occurred over 3 days during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of daily micturitions that occurred during the week of placebo run-in prior to Week 0 visit.

Sponsors and collaborators

Lead sponsor

Jeil Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: Jun 8, 2021
Registry last updated: Jan 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed