Exploratory Trial of TAS-303 in Female Patients With Stress Urinary Incontinence
NCT ID: NCT02906683
Last Updated: 2024-09-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
337 participants
INTERVENTIONAL
2016-10-20
2018-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Phase 2 Study of TAS-303 in Female Patients With Stress Urinary Incontinence
NCT04512053
A Study of TAS-303 in Female Patients With Stress Urinary Incontinence
NCT02562807
Exploratory Study of TAC-302 in Detrusor Underactivity Patients With Overactive Bladder.
NCT03175029
A Phase 2, Randomized, Placebo-controlled, Double-blind Study of EG017 in Female Patients With Stress Urinary Incontinence
NCT05674045
Therapeutic Efficacy and Safety of Mirabegron Treatment on Patients With Overactive Bladder Syndrome in Taiwan
NCT03044912
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TAS-303 3mg
TAS-303
Oral administration for 8 weeks, once daily.
TAS-303 6mg
TAS-303
Oral administration for 8 weeks, once daily.
Placebo
Placebo
Oral administration for 8 weeks, once daily.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TAS-303
Oral administration for 8 weeks, once daily.
Placebo
Oral administration for 8 weeks, once daily.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
20 Years
79 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Taiho Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Taiho Pharmaceutical Co., Ltd
Role: STUDY_DIRECTOR
Taiho Pharmaceutical Co., Ltd.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Taiho Pharmaceutical Co., Ltd selected site
Osaka, , Japan
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
10060050
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.