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

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03175029
• Other study ID #: 10054040
• Status: Completed
• Phase: Phase 2
• Start date: August 1, 2017
• Est. completion date: March 27, 2020

Study information

• Verified date: August 2020
• Source: Taiho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of TAC-302 in detrusor underactivity patients with overactive bladder.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: March 27, 2020
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Detrusor Underactivity
• Hypokinesia
• Overactive Bladder
• Urinary Bladder, Overactive
• Urinary Bladder, Underactive

Intervention

Drug:
• TAC-302
TAC-302 200 mg administered orally twice per day after meals, for 12 weeks.
• Placebo
Placebo administered orally twice per day after meals, for 12 weeks.

Locations

Country	Name	City	State
Japan	Taiho Pharmaceutical Co., Ltd selected site	Kumamoto

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Primary	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.	12 weeks
Secondary	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	Baseline, 12 weeks
Secondary	Bladder compliance	The urodynamic parameter of pressure-flow study during filling phase Bladder compliance in milliliters per centimeters water	Baseline, 12 weeks
Secondary	Appearance of bladder involuntary contraction	The urodynamic parameter of pressure-flow study during filling phase	Baseline, 12 weeks
Secondary	Qmax	The urodynamic parameter of pressure-flow study during voiding phase Qmax in milliliters per second	Baseline, 12 weeks
Secondary	PdetQmax	The urodynamic parameter of pressure-flow study during voiding phase PdetQmax in centimeters water	Baseline, 12 weeks
Secondary	Bladder contraction duration	The urodynamic parameter of pressure-flow study during voiding phase Bladder contraction duration in seconds	Baseline, 12 weeks
Secondary	Maximum free flow rate (free Qmax)	The urodynamic parameter of free uroflowmetry Free Qmax in milliliters per second	Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary	Voided volume	The urodynamic parameter of free uroflowmetry Voided volume in milliliters	Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary	Voiding time	The urodynamic parameter of free uroflowmetry Voiding time in seconds	Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary	Post Void Residual	Determining the volume of post void residual by ultrasonography Post Void Residual in milliliters	Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary	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	Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary	The changes in the international prostate symptom score (IPSS)		Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary	The changes in the overactive bladder symptom score (OABSS)		Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary	The changes in the king's health questionnaire (KHQ)		Baseline, 12 weeks
Secondary	The changes in mean urinary frequency per day, mean frequency of urgency and urge urinary incontinence episodes per day	The bladder diary data	Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary	Safety assessed by incidence rate and severity of adverse events		Up to 13 Weeks