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

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ClinicalTrials.gov Identifier: NCT03566134
Recruitment Status : Recruiting
First Posted : June 21, 2018
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: DA-8010 Placebo Drug: DA-8010 2.5mg Drug: DA-8010 5mg Drug: Solifenacin 5mg Drug: Solifenacin succinate placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Therapeutic Exploratory Clinical Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder
Actual Study Start Date : July 10, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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

Drug: Solifenacin succinate placebo
Participants receive placebo to match solifenacin 5 mg orally once a day.

Experimental: DA-8010 5mg
DA-8010 5mg + Solifenacin succinate placebo
Drug: DA-8010 5mg
Participants receive DA-8010 5mg orally once a day.

Drug: Solifenacin succinate placebo
Participants receive placebo to match solifenacin 5 mg 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.




Primary Outcome Measures :
  1. Change From Baseline in mean number of micturitions per 24 hours [ Time Frame: 12 weeks ]
    Change from baseline to Week 12 in mean number of micturitions per 24 hours



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03566134


Contacts
Contact: Jang Hwan Kim, PhD 82-2-2228-2319 jkim@yuhs.ac

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jang Hwan Kim, PhD    82-2-2228-2319    jkim@yuhs.ac   
Principal Investigator: Jang Hwan Kim, PhD         
Sponsors and Collaborators
Dong-A ST Co., Ltd.

Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT03566134     History of Changes
Other Study ID Numbers: DA8010_OAB_II
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Solifenacin Succinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents