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Completed

NCT Number: NCT03175029

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

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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Key information

Conditions

Detrusor Underactivity Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Overactive Bladder Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Bladder, Underactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Taiho Pharmaceutical Co., Ltd selected site

Kumamoto, Japan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

TAC-302

Drug

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

Placebo

Drug

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

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: Baseline to Week 12

    BVE indicates Voided volume / (voided volume + post void residual): calculated from the voided volume measured by uroflowmetry and the post void residual measured by ultrasonography.

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

    Time frame: Baseline to Week 12

    BVE indicates Voided volume / (voided volume + post void residual): calculated from the voided volume measured by uroflowmetry and the post void residual measured by ultrasonography.

  3. 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)

    Time frame: Baseline to Week 12

    BVE indicates Voided volume / (voided volume + post void residual): calculated from the voided volume measured by uroflowmetry and the post void residual measured by ultrasonography.

  4. Number of Micturitions Per 24 Hours at Baseline and Week 12

    Time frame: Baseline to Week 12

    On the basis of information from bladder diary records in the 3 days directly before each evaluation timepoint, an average of urinations per 24 hours was calculated. The patients with at least 8 urinations per 24 hours at registration were included in this study.

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

    Time frame: Baseline to Week 12

    On the basis of information from bladder diary records in the 3 days directly before each evaluation timepoint, an average of urinary urgency episodes per 24 hours was calculated. The patients with at least one urinary urgency episode per 24 hours at registration were included in this study.

  6. Overactive Bladder Symptom Score (OABSS) Total Score at Baseline and Week 12

    Time frame: Baseline to Week 12

    Overactive bladder symptoms were evaluated using the OABSS. The OABSS Total Score is the sum of four symptom scores: daytime frequency (score 0-2), nighttime frequency (score 0-3), urgency (score 0-5), and urgency incontinence (score 0-5). The range of scores is from 0 to 15 points with a higher score indicating greater severity. A score ≤ 5 was determined to be mild, a score of 6 to 11 was determined to be moderate and a score ≥ 12 was determined to be severe.

  7. Number of Participants With Adverse Events

    Time frame: Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)

    In tabulation of adverse events, the diagnoses entered on eCRFs were coded using the medical dictionary for regulatory activities (MedDRA) ver.22.1, and were presented as MedDRA preferred terms.

  8. Number of Participants With Adverse Drug Reactions

    Time frame: Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)

  9. Number of Participants With Serious Adverse Events

    Time frame: Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)

    In tabulation of adverse events, the diagnoses entered on eCRFs were coded using the medical dictionary for regulatory activities (MedDRA) ver.22.1, and were presented as MedDRA preferred terms.

  10. Number of Participants With Adverse Events Leading to Death

    Time frame: Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)

  11. Number of Participants With Adverse Events Leading to Dose Discontinuation

    Time frame: Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)

  12. Number of Participants With Adverse Events Leading to Dose Interruption

    Time frame: Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)

    In tabulation of adverse events, the diagnoses entered on eCRFs were coded using the medical dictionary for regulatory activities (MedDRA) ver.22.1, and were presented as MedDRA preferred terms.

Sponsors and collaborators

Lead sponsor

Taiho Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jun 5, 2017
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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