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

NCT03566134 | Completed Phase 2

• 1 other identifier: DA8010_OAB_II
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 1

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

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Placebo

PLACEBO COMPARATOR

DA-8010 placebo + Solifenacin succinate placebo

Drug: DA-8010 Placebo; Drug: Solifenacin succinate placebo

DA-8010 2.5mg

EXPERIMENTAL

DA-8010 2.5mg + Solifenacin succinate placebo

Drug: DA-8010 2.5mg; Drug: Solifenacin succinate placebo

DA-8010 5mg

EXPERIMENTAL

DA-8010 5mg + Solifenacin succinate placebo

Drug: DA-8010 5mg; Drug: Solifenacin succinate placebo

Solifenacin 5mg

ACTIVE COMPARATOR

DA-8010 placebo + Solifenacin succinate 5mg

Drug: DA-8010 Placebo; Drug: Solifenacin 5mg

Interventions

DA-8010 Placebo DRUG

Participants receive placebo to match DA-8010 orally once a day.

Placebo; Solifenacin 5mg

DA-8010 2.5mg DRUG

Participants receive DA-8010 2.5mg orally once a day.

DA-8010 2.5mg

DA-8010 5mg DRUG

Participants receive DA-8010 5mg orally once a day.

DA-8010 5mg

Solifenacin 5mg DRUG

Participants receive solifenacin 5 mg orally once a day.

Solifenacin 5mg

Solifenacin succinate placebo DRUG

Participants receive placebo to match solifenacin 5 mg orally once a day.

DA-8010 2.5mg; DA-8010 5mg; Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-A ST Co., Ltd.: lead

Study Sites (1)

Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

DA-8010; Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: June 21, 2018
• Study Start: July 10, 2018
• Primary Completion: December 27, 2019
• Study Completion: December 27, 2019
• Last Updated: February 7, 2020

Record last verified: 2018-07

Locations

KR (1)