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

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

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

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: DA-8010 Placebo; Drug: Solifenacin succinate placebo; Drug: DA-8010 2.5mg; Drug: DA-8010 5mg; Drug: Solifenacin 5mg

• Study Type: Interventional
• Enrollment (Actual): 306
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; DA-8010 placebo + Solifenacin succinate placebo	Drug: DA-8010 Placebo; Participants receive placebo to match DA-8010 orally once a day.; Drug: Solifenacin succinate placebo; Participants receive placebo to match solifenacin 5 mg orally once a day.
Experimental: DA-8010 2.5mg; DA-8010 2.5mg + Solifenacin succinate placebo	Drug: Solifenacin succinate placebo; Participants receive placebo to match solifenacin 5 mg orally once a day.; Drug: DA-8010 2.5mg; Participants receive DA-8010 2.5mg orally once a day.
Experimental: DA-8010 5mg; DA-8010 5mg + Solifenacin succinate placebo	Drug: Solifenacin succinate placebo; Participants receive placebo to match solifenacin 5 mg orally once a day.; Drug: DA-8010 5mg; Participants receive DA-8010 5mg orally once a day.
Active Comparator: Solifenacin 5mg; DA-8010 placebo + Solifenacin succinate 5mg	Drug: DA-8010 Placebo; Participants receive placebo to match DA-8010 orally once a day.; Drug: Solifenacin 5mg; Participants receive solifenacin 5 mg orally once a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in mean number of micturitions per 24 hours	Change from baseline to Week 12 in mean number of micturitions per 24 hours	12 weeks

Collaborators and Investigators

• Sponsor: Dong-A ST Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2018
• Primary Completion (Actual): December 27, 2019
• Study Completion (Actual): December 27, 2019

Study Registration Dates

• First Submitted: June 12, 2018
• First Submitted That Met QC Criteria: June 12, 2018
• First Posted (Actual): June 21, 2018

Study Record Updates

• Last Update Posted (Actual): February 7, 2020
• Last Update Submitted That Met QC Criteria: February 6, 2020
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Solifenacin Succinate; DA-8010
• Other Study ID Numbers: DA8010_OAB_II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No