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

May 27, 2024 updated by: Taiho Pharmaceutical Co., Ltd.

A Phase IIa Study 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
337

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Osaka, Japan
        • Taiho Pharmaceutical Co., Ltd selected site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Oral administration for 8 weeks, once daily.
Experimental: TAS-303 3mg
Drug: TAS-303
Oral administration for 8 weeks, once daily.
Experimental: TAS-303 6mg
Drug: TAS-303
Oral administration for 8 weeks, once daily.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 8
Time Frame: Baseline to Week 8 (8 weeks in treatment period)
Baseline to Week 8 (8 weeks in treatment period)
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)
Baseline to Week 8 (8 weeks in treatment period)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incontinence Episode Frequency (IEF) Per 24 Hours at Baseline and Week 4
Time Frame: Baseline to Week 4 (4 weeks in treatment period)
Baseline to Week 4 (4 weeks in treatment period)
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)
Baseline to Week 4 (4 weeks in treatment period)
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)
Baseline to Week 4 (4 weeks in treatment period)
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)
Baseline to Week 4 (4 weeks in treatment period)
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)
Baseline to Week 8 (8 weeks in treatment period)
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)
Baseline to Week 8 (8 weeks in treatment period)
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
At Week 8 in the treatment period
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".
Baseline to Week 8 (8 weeks in treatment period)
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.
Baseline to Week 8 (8 weeks in treatment period)
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.
Baseline to Week 8 (8 weeks in treatment period)
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.
Baseline to Week 8 (8 weeks in treatment period)
Serious Adverse Events
Time Frame: Baseline to Week 8 (8 weeks in treatment period)
Baseline to Week 8 (8 weeks in treatment period)
Adverse Events Leading to Discontinuation of Administration
Time Frame: Baseline to Week 8 (8 weeks in treatment period)
Baseline to Week 8 (8 weeks in treatment period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taiho Pharmaceutical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Taiho Pharmaceutical Co., Ltd, Taiho Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 20, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 20, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10060050

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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