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

Dong-A ST

Status and phase: Completed; Phase 2

Conditions: Overactive Bladder

Treatments: Drug: DA-8010 5mg; Drug: Solifenacin 5mg; Drug: DA-8010 2.5mg; Drug: DA-8010 Placebo; Drug: Solifenacin succinate placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03566134

DA8010_OAB_II

Details and patient eligibility

About

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

Enrollment: 306 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

306 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

DA-8010 placebo + Solifenacin succinate placebo

Treatment:

Drug: DA-8010 Placebo

Drug: Solifenacin succinate placebo

DA-8010 2.5mg

Experimental group

Description:

DA-8010 2.5mg + Solifenacin succinate placebo

Treatment:

Drug: Solifenacin succinate placebo

Drug: DA-8010 2.5mg

DA-8010 5mg

Experimental group

Description:

DA-8010 5mg + Solifenacin succinate placebo

Treatment:

Drug: Solifenacin succinate placebo

Drug: DA-8010 5mg

Solifenacin 5mg

Active Comparator group

Description:

DA-8010 placebo + Solifenacin succinate 5mg

Treatment:

Drug: DA-8010 Placebo

Drug: Solifenacin 5mg