A Therapeutic Exploratory Clinical Study of DA-8010 in Pa... | NCT03566134

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

NCT03566134

Sponsor

Dong-A ST Co., Ltd.

Status

Completed

Last Update Posted

Feb 7, 2020Actual

Enrollment

306Actual

Phase

Phase 2

Conditions

Overactive Bladder

Interventions

DA-8010 Placebo
DA-8010 2.5mg
DA-8010 5mg
Solifenacin 5mg
Solifenacin succinate placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 10, 2018Actual

Primary Completion Date

Dec 27, 2019Actual

Completion Date

Dec 27, 2019Actual

First Submitted Date

Jun 12, 2018

First Submission Date that Met QC Criteria

Jun 12, 2018

First Posted Date

Jun 21, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2020

Last Update Posted Date

Feb 7, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

306Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
DA-8010 Placebo	Drug	Participants receive placebo to match DA-8010 orally once a day.	Placebo Solifenacin 5mg

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D053201	Urinary Bladder, Overactive

Ancestor Terms

ID	Term
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000630740	DA-8010
D000069464	Solifenacin Succinate

Ancestor Terms

ID	Term
D011812	Quinuclidines
D006572	Heterocyclic Compounds, Bridged-Ring
D006571	Heterocyclic Compounds
D044005	Tetrahydroisoquinolines

Browse Leaves

Not provided

Browse Branches

Not provided