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Exploratory Study of TAC-302 in Detrusor Underactivity Patients With Overactive Bladder.

Primary Purpose

Detrusor Underactivity, Overactive Bladder

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
TAC-302
Placebo
Sponsored by
Taiho Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Detrusor Underactivity focused on measuring Lower Urinary Tract Symptoms

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • To have Lower Urinary Tract Symptoms for at least 12 weeks prior to study entry
  • To have at least 1 urinary urgency episodes per day, and diurnal urinary frequency of 8 or more per day.
  • To meet the detrusor underactivity criteria by urodynamic study

Key Exclusion Criteria:

  • Neurogenic bladder by the central nervous system diseases.
  • StageIII or more cystocele of pelvic organ prolapse quantification system (women)
  • Prostate volume ≥30mL (Men)
  • Any symptoms of Urinary tract infection (UTI)

Sites / Locations

  • Taiho Pharmaceutical Co., Ltd selected site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TAC-302

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Male; bladder contractility index (BCI)
Pressure-flow study parameters of the detrusor pressure at maximum flow rate (PdetQmax) and the maximum flow rate (Qmax) will be combined to report BCI. BCI=PdetQmax + 5Qmax The detrusor pressure at maximum flow rate (PdetQmax) in centimeters water, the maximum flow rate (Qmax) in milliliters per second.
Female; projected isovolumetric pressure (PIP) 1
Pressure-flow study parameters of the detrusor pressure at maximum flow rate (PdetQmax) and the maximum flow rate (Qmax) will be combined to report PIP1. PIP1=PdetQmax + Qmax The detrusor pressure at maximum flow rate (PdetQmax) in centimeters water, the maximum flow rate (Qmax) in milliliters per second.

Secondary Outcome Measures

Bladder capacity of first desire to void
The urodynamic parameter of pressure-flow study during filling phase Bladder capacity of first desire to void in milliliters
Bladder compliance
The urodynamic parameter of pressure-flow study during filling phase Bladder compliance in milliliters per centimeters water
Appearance of bladder involuntary contraction
The urodynamic parameter of pressure-flow study during filling phase
Qmax
The urodynamic parameter of pressure-flow study during voiding phase Qmax in milliliters per second
PdetQmax
The urodynamic parameter of pressure-flow study during voiding phase PdetQmax in centimeters water
Bladder contraction duration
The urodynamic parameter of pressure-flow study during voiding phase Bladder contraction duration in seconds
Maximum free flow rate (free Qmax)
The urodynamic parameter of free uroflowmetry Free Qmax in milliliters per second
Voided volume
The urodynamic parameter of free uroflowmetry Voided volume in milliliters
Voiding time
The urodynamic parameter of free uroflowmetry Voiding time in seconds
Post Void Residual
Determining the volume of post void residual by ultrasonography Post Void Residual in milliliters
Bladder Voiding Efficiency (BVE)
Voided volume and Post Void Residual will be combined to report BVE BVE(%)=[Voided volume/(Voided volume+ Post Void Residual)]×100
The changes in the international prostate symptom score (IPSS)
The changes in the overactive bladder symptom score (OABSS)
The changes in the king's health questionnaire (KHQ)
The changes in mean urinary frequency per day, mean frequency of urgency and urge urinary incontinence episodes per day
The bladder diary data
Safety assessed by incidence rate and severity of adverse events

Full Information

First Posted
May 25, 2017
Last Updated
August 26, 2020
Sponsor
Taiho Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03175029
Brief Title
Exploratory Study of TAC-302 in Detrusor Underactivity Patients With Overactive Bladder.
Official Title
Exploratory Study of TAC-302 in Detrusor Underactivity Patients With Overactive Bladder.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
March 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiho Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of TAC-302 in detrusor underactivity patients with overactive bladder.
Detailed Description
The main purpose of this study is to assess the efficacy of TAC-302 for 12 weeks in detrusor underactivity patients with overactive bladder by measuring the following parameters of pressure-flow study. Male; bladder contractility index (BCI) Female; projected isovolumetric pressure (PIP) 1

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Detrusor Underactivity, Overactive Bladder
Keywords
Lower Urinary Tract Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAC-302
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
TAC-302
Intervention Description
TAC-302 200 mg administered orally twice per day after meals, for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered orally twice per day after meals, for 12 weeks.
Primary Outcome Measure Information:
Title
Male; bladder contractility index (BCI)
Description
Pressure-flow study parameters of the detrusor pressure at maximum flow rate (PdetQmax) and the maximum flow rate (Qmax) will be combined to report BCI. BCI=PdetQmax + 5Qmax The detrusor pressure at maximum flow rate (PdetQmax) in centimeters water, the maximum flow rate (Qmax) in milliliters per second.
Time Frame
12 weeks
Title
Female; projected isovolumetric pressure (PIP) 1
Description
Pressure-flow study parameters of the detrusor pressure at maximum flow rate (PdetQmax) and the maximum flow rate (Qmax) will be combined to report PIP1. PIP1=PdetQmax + Qmax The detrusor pressure at maximum flow rate (PdetQmax) in centimeters water, the maximum flow rate (Qmax) in milliliters per second.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Bladder capacity of first desire to void
Description
The urodynamic parameter of pressure-flow study during filling phase Bladder capacity of first desire to void in milliliters
Time Frame
Baseline, 12 weeks
Title
Bladder compliance
Description
The urodynamic parameter of pressure-flow study during filling phase Bladder compliance in milliliters per centimeters water
Time Frame
Baseline, 12 weeks
Title
Appearance of bladder involuntary contraction
Description
The urodynamic parameter of pressure-flow study during filling phase
Time Frame
Baseline, 12 weeks
Title
Qmax
Description
The urodynamic parameter of pressure-flow study during voiding phase Qmax in milliliters per second
Time Frame
Baseline, 12 weeks
Title
PdetQmax
Description
The urodynamic parameter of pressure-flow study during voiding phase PdetQmax in centimeters water
Time Frame
Baseline, 12 weeks
Title
Bladder contraction duration
Description
The urodynamic parameter of pressure-flow study during voiding phase Bladder contraction duration in seconds
Time Frame
Baseline, 12 weeks
Title
Maximum free flow rate (free Qmax)
Description
The urodynamic parameter of free uroflowmetry Free Qmax in milliliters per second
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
Title
Voided volume
Description
The urodynamic parameter of free uroflowmetry Voided volume in milliliters
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
Title
Voiding time
Description
The urodynamic parameter of free uroflowmetry Voiding time in seconds
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
Title
Post Void Residual
Description
Determining the volume of post void residual by ultrasonography Post Void Residual in milliliters
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
Title
Bladder Voiding Efficiency (BVE)
Description
Voided volume and Post Void Residual will be combined to report BVE BVE(%)=[Voided volume/(Voided volume+ Post Void Residual)]×100
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
Title
The changes in the international prostate symptom score (IPSS)
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
Title
The changes in the overactive bladder symptom score (OABSS)
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
Title
The changes in the king's health questionnaire (KHQ)
Time Frame
Baseline, 12 weeks
Title
The changes in mean urinary frequency per day, mean frequency of urgency and urge urinary incontinence episodes per day
Description
The bladder diary data
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
Title
Safety assessed by incidence rate and severity of adverse events
Time Frame
Up to 13 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: To have Lower Urinary Tract Symptoms for at least 12 weeks prior to study entry To have at least 1 urinary urgency episodes per day, and diurnal urinary frequency of 8 or more per day. To meet the detrusor underactivity criteria by urodynamic study Key Exclusion Criteria: Neurogenic bladder by the central nervous system diseases. StageIII or more cystocele of pelvic organ prolapse quantification system (women) Prostate volume ≥30mL (Men) Any symptoms of Urinary tract infection (UTI)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taiho Pharmaceutical Co., Ltd
Organizational Affiliation
Taiho Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Taiho Pharmaceutical Co., Ltd selected site
City
Kumamoto
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
36205739
Citation
Yoshida M, Gotoh M, Yokoyama O, Kakizaki H, Yamanishi T, Yamaguchi O. Efficacy of TAC-302 for patients with detrusor underactivity and overactive bladder: a randomized, double-blind, placebo-controlled phase 2 study. World J Urol. 2022 Nov;40(11):2799-2805. doi: 10.1007/s00345-022-04163-4. Epub 2022 Oct 7.
Results Reference
derived

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Exploratory Study of TAC-302 in Detrusor Underactivity Patients With Overactive Bladder.

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