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

NCT05282069 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 607

Last updated 2024-06-26

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Dong-A ST Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-12
Primary Completion
2023-11-01
Completion
2024-05-29

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05282069 on ClinicalTrials.gov