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

NCT03175029 | Completed Phase 2 Results

• 1 other identifier: 10054040
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Detrusor Underactivity; Overactive Bladder

Keywords

Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (2)

• Changes in the Mean BCI for Male From Baseline to Week 12

  BCI indicates maxim um detrusor pressure at peak urine flow (PdetQmax) + 5 × peak urine flow rate (Qmax): PdetQmax and Qmax denotes detrusor pressure at maximum flow and maximum flow rate in pressure flow study, respectively. This index is used to assess detrusor contractility in men, with a higher value indicating greater detrusor contractility. Contractility can be divided into strong \> 150, normal 100-150, and weak \< 100. No theoretical minimum and maximum value of the scale range exists.

  Baseline to Week 12

• Changes in the Mean PIP1 for Female From Baseline to Week 12

  PIP1 indicates PdetQma x + Qmax: PdetQmax and Qmax denotes detrusor pressure at maximum flow and maximum flow rate in pressure flow study, respectively. This index is used to assess detrusor contractility in women, with a higher value indicating greater detrusor contractility. Contractility can be divided into strong \> 75, normal 30-75, and weak \< 30. No theoretical minimum and maximum value of the scale range exists.

  Baseline to Week 12

Secondary Outcomes (12)

• Changes in the Mean BVE From Baseline to Week 12 (Overall)

  Baseline to Week 12

• Changes in the Mean BVE From Baseline to Week 12 (In the Subgroup of Patients With Post Void Residual ≥ 50 mL at Baseline)

  Baseline to Week 12

• Changes in the Mean BVE for Female From Baseline to Week 12 (In the Subgroup of Patients With Post Void Residual ≥ 100 mL at Baseline)

  Baseline to Week 12

• Number of Micturitions Per 24 Hours at Baseline and Week 12

  Baseline to Week 12

• Number of Urinary Urgency Episodes Per 24 Hours at Baseline and Week 12

  Baseline to Week 12

Study Arms (2)

TAC-302

EXPERIMENTAL

Drug: TAC-302

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TAC-302 DRUG

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

TAC-302

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Taiho Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Taiho Pharmaceutical Co., Ltd selected site

Kumamoto, Japan

Location

Related Publications (1)

• 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.

  PMID: 36205739 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Underactive; Urinary Bladder, Overactive; Lower Urinary Tract Symptoms

Interventions

tac-302

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Taiho Pharmaceutical Co., Ltd.
• Organization: Clinical Trial Registration Contact

toiawase@taiho.co.jp

+81-3-3293-2455

Study Officials

• Taiho Pharmaceutical Co., Ltd

  Taiho Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2017
• First Posted: June 5, 2017
• Study Start: September 9, 2017
• Primary Completion: November 1, 2019
• Study Completion: March 27, 2020
• Last Updated: January 20, 2025
• Results First Posted: January 20, 2025

Record last verified: 2024-12

Locations

JP (1)