A Therapeutic Exploratory Clinical Study of DA-8010 in Patients With Overactive Bladder

Phase 2

Completed

• Conditions: Overactive Bladder
• Interventions: Drug: DA-8010 5mg; Drug: DA-8010 Placebo; Drug: DA-8010 2.5mg; Drug: Solifenacin succinate placebo; Drug: Solifenacin 5mg

• Registration Number: NCT03566134
• Lead Sponsor: Dong-A ST Co., Ltd.

Brief Summary

A Therapeutic Exploratory Clinical Study to evaluate the efficacy and safety of DA-8010 in Patients with Overactive Bladder and to determine the optimal dose of DA-8010

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-12
• Study First Submitted QC: 2018-06-12
• Study First Posted: 2018-06-21
• Status Verified: 2018-07
• Study Start: 2018-07-10
• Primary Completion: 2019-12-27
• Study Completion: 2019-12-27
• Last Update Submitted: 2020-02-06
• Last Update Posted: 2020-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 306

Inclusion Criteria

Main Inclusion at Screening (Visit 1):

• Men and women 19 years or older with OAB symptoms for ≥ 3 months.
• Subject who is willing and able to complete the micturition diary correctly.
• Subject who is willing and able to provide informed consent indicating that they understand the purpose and procedures required for the study

Exclusion Criteria

• Clinically significant Stress urinary incontinence or Mixed urinary incontinence where stress is the predominant factor
• Diagnosed with interstitial cystitis or bladder pain syndrome
• Clinically significant pelvic organ prolapse
• Subject who has neurologic status which is able to effect vesical function, such as multiple sclerosis, Spinal Injury or Parkinson's disease
• Medical history of malignant tumor in urinary system or pelvic organs
• Clinically significant bladder outlet obstruction or more than 200mL of post-void residual volume

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Solifenacin succinate placebo	DA-8010 placebo + Solifenacin succinate placebo
DA-8010 2.5mg	Solifenacin succinate placebo	DA-8010 2.5mg + Solifenacin succinate placebo
DA-8010 5mg	DA-8010 5mg	DA-8010 5mg + Solifenacin succinate placebo
Placebo	DA-8010 Placebo	DA-8010 placebo + Solifenacin succinate placebo
DA-8010 5mg	Solifenacin succinate placebo	DA-8010 5mg + Solifenacin succinate placebo
Solifenacin 5mg	Solifenacin 5mg	DA-8010 placebo + Solifenacin succinate 5mg
DA-8010 2.5mg	DA-8010 2.5mg	DA-8010 2.5mg + Solifenacin succinate placebo
Solifenacin 5mg	DA-8010 Placebo	DA-8010 placebo + Solifenacin succinate 5mg

Primary Outcome Measures

Name	Time	Method
Change From Baseline in mean number of micturitions per 24 hours	12 weeks	Change from baseline to Week 12 in mean number of micturitions per 24 hours

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of