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

Taiho Pharma

Status and phase: Completed; Phase 2

Conditions: Detrusor Underactivity; Overactive Bladder

Treatments: Drug: TAC-302; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03175029

10054040

Details and patient eligibility

About

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

Full 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

Enrollment: 195 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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195 participants in 2 patient groups, including a placebo group

TAC-302

Experimental group

Treatment:

Drug: TAC-302

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo