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Completed

NCT Number: NCT02906683

Exploratory Trial of TAS-303 in Female Patients With Stress Urinary Incontinence

The purpose of this study is to evaluate the efficacy and safety of TAS-303 in female patients with stress urinary incontinence.

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

20 year–79 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Taiho Pharmaceutical Co., Ltd selected site

Osaka, Japan

About this study

The main purpose of this study is to assess the efficacy of TAS-303 for 8 weeks in female patients with stress urinary incontinence (SUI) compared with placebo as measured by the percent change in incontinence episode frequency (IEF) from baseline.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient has symptoms of Stress Urinary Incontinence (SUI) for at least 12 weeks prior to study entry
  • Patient has at least 1 incontinence episodes per day, and urinary diurnal frequency of 10 or less per day and nocturia of 2 or less per day.
  • Patient is positive in 1-hour pad weight test

Exclusion criteria

  • Patient has predominant or primary urge incontinence according to investigator judgment
  • Patient had a prior surgical SUI treatment
  • Patient is diagnosed stageII or more of Pelvic Organ Prolapse
  • Patient has symptoms of Urinary tract infection (UTI)
  • Patient is positive pregnancy test
  • Patient has on physical examination, neurological and/or vaginal examination results which, in the opinion of the investigator, should exclude the subject.

Treatment and study plan

TAS-303

Drug

Oral administration for 8 weeks, once daily.

Placebo

Drug

Oral administration for 8 weeks, once daily.

Primary outcomes

  1. Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8

    Time frame: Baseline to Week 8 (8 weeks in treatment period)

  2. Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8

    Time frame: Baseline to Week 8 (8 weeks in treatment period)

Secondary outcomes

  1. Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4

    Time frame: Baseline to Week 4 (4 weeks in treatment period)

  2. Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4

    Time frame: Baseline to Week 4 (4 weeks in treatment period)

  3. Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4 in SUI Subgroup

    Time frame: Baseline to Week 4 (4 weeks in treatment period)

  4. Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 4 in SUI Subgroup

    Time frame: Baseline to Week 4 (4 weeks in treatment period)

  5. Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8 in SUI Subgroup

    Time frame: Baseline to Week 8 (8 weeks in treatment period)

  6. Mean Percentage Changes in Incontinence Episode Frequency (IEF) Per 24 Hours From Baseline to Week 8 in SUI Subgroup

    Time frame: Baseline to Week 8 (8 weeks in treatment period)

  7. Percentages of the Patients With an Incontinence Amount of ≤ 2.0 g (Deemed Dryness) in the 1-hour Pad Test at Week 8 in the Treatment Period

    Time frame: At Week 8 in the treatment period

  8. Patient Global Impression-Improvement (PGI-I) Rates at Baseline, Week 4 and Week 8

    Time frame: Baseline to Week 8 (8 weeks in treatment period)

    PGI-I was used to evaluate the patients' impression of improvement of urinary incontinence.

    The improvement of PGI-I was defined as the selection of "Very much better", "Much better", or "A little better".

    The investigator or subinvestigator instructed patients to evaluate the improvement of urinary incontinence at the evaluation time point using the following 7-point scale: (1) "Very much better"; (2) "Much better"; (3) "A little better"; (4) "No change"; (5) "A little worse"; (6) "Much worse"; and (7) "Very much worse".

  9. Any Adverse Events

    Time frame: Baseline to Week 8 (8 weeks in treatment period)

    For tabulation of adverse events, the terms of diagnosis recorded in the eCRFs were converted according to the Medical Dictionary for Regulatory Activities (MedDRA) ver. 20.1 and were expressed as preferred terms of MedDRA.

  10. Advese Events Occurring in ≥2% of Patients in Any Treatment Group During the Treatment Period

    Time frame: Baseline to Week 8 (8 weeks in treatment period)

    For tabulation of adverse events, the terms of diagnosis recorded in the eCRFs were converted according to the Medical Dictionary for Regulatory Activities (MedDRA) ver. 20.1 and were expressed as preferred terms of MedDRA.

  11. Adverse Drug Reactions

    Time frame: Baseline to Week 8 (8 weeks in treatment period)

    For tabulation of adverse events, the terms of diagnosis recorded in the eCRFs were converted according to the Medical Dictionary for Regulatory Activities (MedDRA) ver. 20.1 and were expressed as preferred terms of MedDRA.

  12. Serious Adverse Events

    Time frame: Baseline to Week 8 (8 weeks in treatment period)

  13. Adverse Events Leading to Discontinuation of Administration

    Time frame: Baseline to Week 8 (8 weeks in treatment period)

Sponsors and collaborators

Lead sponsor

Taiho Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase IIa Study of TAS-303 in Female Patients With Stress Urinary Incontinence

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 20, 2016
Registry last updated
Sep 26, 2024

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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