NCT05282069

A Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder

A Multicenter, Double-blind, Placebo-controlled and Active-reference, Randomized, Parallel, Therapeutic Confirmatory Clinical Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 607 (actual)
• Sponsor: Dong-A ST Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of DA-8010 in patients with overactive bladder for 12 weeks as double-blind, placebo-controlled and active-reference study, and also will evaluate the long-term safety of DA-8010 for 52 weeks in patients with overactive bladder as open-label study.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
DRUG	DA-8010 Placebo	Participants receive placebo to match DA-8010 orally once a day.
DRUG	DA-8010 2.5mg	Participants receive DA-8010 2.5mg orally once a day.
DRUG	DA-8010 5mg	Participants receive DA-8010 5mg orally once a day.
DRUG	Solifenacin 5mg	Participants receive solifenacin 5 mg orally once a day.
DRUG	Solifenacin succinate placebo	Participants receive placebo to match solifenacin 5 mg orally once a day.

Timeline

• Start date: 2022-05-12
• Primary completion: 2023-11-01
• Completion: 2024-05-29
• First posted: 2022-03-16
• Last updated: 2024-06-26

Locations

1 site across 1 country: South Korea