NCT04917315

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: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Jeil Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	JLP-2002 A mg	administration of JLP-2002 Participants received one vibegron A mg tablet, taken orally each morning, for 12 weeks.
DRUG	Placebo	administration of Placebo Participants received one placebo tablet, taken orally each morning, for 12 weeks.

Timeline

• Start date: 2020-05-21
• Primary completion: 2021-08-18
• Completion: 2021-08-18
• First posted: 2021-06-08
• Last updated: 2022-01-28

Locations

1 site across 1 country: South Korea