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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

195 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-09

Study Completion Date

2020-03-27

Brief Summary

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

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Detailed Description

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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

Conditions

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Detrusor Underactivity Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TAC-302

Group Type EXPERIMENTAL

TAC-302

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo administered orally twice per day after meals, for 12 weeks.

Interventions

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TAC-302

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

Intervention Type DRUG

Placebo

Placebo administered orally twice per day after meals, for 12 weeks.

Intervention Type DRUG

Eligibility Criteria

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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

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)

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No