Stress Urinary IncontinencePhase 1NCT02562807
A Study of TAS-303 in Female Patients With Stress Urinary Incontinence
A Phase 1 study testing TAS-303 18mg single-dose and TAS-303 9mg single-dose in people with Stress Urinary Incontinence, run by Taiho Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate pharmacological effect, safety and pharmacokinetic of TAS-303 in female patients with Stress Urinary Incontinence. Read more about this study
- Who is it for?
- Ages 20 to 64 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- TAS-303 18mg single-dose and TAS-303 9mg single-dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2015to Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patient has symptoms of Stress Urinary Incontinence (SUI) for at least 12 weeks prior to study entry
- Patient weights at least 45 kg and has body mass index (BMI) range of 18.0-30.0 kg/m2, inclusive, at screening
- Patient is positive in 1-hour pad weight test at screening
- Patient has at least 2 incontinence episodes per week.
Who cannot join
- Patient has predominant or primary urge incontinence according to investigator judgment
- Patient had a prior surgical SUI treatment
- Patient is diagnosed Pelvic Organ Prolapse
- Patient is currently taking medication, or has taken medication in the last 4 weeks, for urinary incontinence or that effect urinary output function including anti-cholinergic or anti-histamines or any anti-anxiety medications.
- Patient is positive pregnancy test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of TAS-303 in Female Patients With Stress Urinary Incontinence
The purpose of this study is to evaluate pharmacological effect, safety and pharmacokinetic of TAS-303 in female patients with Stress Urinary Incontinence.
Read the detailed description
This study is double-blind, placebo-controlled crossover study. The main purpose of this study is to evaluate Urethral Pressure Profile Parameters in Stress Urinary Incontinence patients who will receive single dose of TAS-303 or Placebo.
- Conditions
- Stress Urinary Incontinence
- Being tested
- TAS-303 18mg single-dose, Placebo 18mg single-dose, TAS-303 9mg single-dose, Placebo 9mg single-dose
- Keywords
- Urinary Incontinence, Urinary Incontinence, Stress, Lower Urinary Tract Symptoms
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAS-303 18mg single-doseDrug
Placebo 18mg single-doseDrug
TAS-303 9mg single-doseDrug
Placebo 9mg single-doseDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Active comparator | TAS-303 18mg single-dose and then Placebo single-dose. Receives: Drug: TAS-303 18mg single-dose; Drug: Placebo 18mg single-dose |
| Treatment B | Placebo comparator | Placebo single-dose and then TAS-303 18mg single-dose. Receives: Drug: TAS-303 18mg single-dose; Drug: Placebo 18mg single-dose |
| Treatment C | Active comparator | TAS-303 9mg single-dose and then Placebo single-dose. Receives: Drug: TAS-303 9mg single-dose; Drug: Placebo 9mg single-dose |
| Treatment D | Placebo comparator | TAS-303 Placebo single-dose and then TAS-303 9mg single-dose. Receives: Drug: TAS-303 9mg single-dose; Drug: Placebo 9mg single-dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Maximum Urethral Closure Pressure (MUCP)
Measured: Baseline, 6 hours after the administration
Secondary outcomes (6)
Urethral pressure profile parameters: mean urethral closure pressure, functional profile length
Measured: Baseline, 6 hours after the administration
Safety assessed by incidence and severity of adverse events
Measured: Up to 36 days after the administration
Maximum plasma concentration (Cmax) of TAS-303
Measured: 1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration
Time to maximum plasma concentration (tmax) of TAS-303
Measured: 1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration
Area under the plasma concentration versus time curve (AUC) of TAS-303
Measured: Immediately prior to dosing, and 1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration
Elimination half-time (t1/2) of TAS-303
Measured: 1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Taiho Pharmaceutical Co., Ltd., Study director, Taiho Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562807
- Sponsor's protocol ID
- 10060040
- Status last verified
- Aug 2016
- First submitted
- 18 Sep 2015
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of TAS-303 in Female Patients With Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT02562807
- Acronym / sponsor ID
- 10060040
- Conditions
- Stress Urinary Incontinence
- Keywords
- Urinary Incontinence, Urinary Incontinence, Stress, Lower Urinary Tract Symptoms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 29 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate pharmacological effect, safety and pharmacokinetic of TAS-303 in female patients with Stress Urinary Incontinence.
Detailed description
This study is double-blind, placebo-controlled crossover study. The main purpose of this study is to evaluate Urethral Pressure Profile Parameters in Stress Urinary Incontinence patients who will receive single dose of TAS-303 or Placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Active comparator | Drug: TAS-303 18mg single-dose, Drug: Placebo 18mg single-doseTAS-303 18mg single-dose and then Placebo single-dose. |
| Treatment B | Placebo comparator | Drug: TAS-303 18mg single-dose, Drug: Placebo 18mg single-dosePlacebo single-dose and then TAS-303 18mg single-dose. |
| Treatment C | Active comparator | Drug: TAS-303 9mg single-dose, Drug: Placebo 9mg single-doseTAS-303 9mg single-dose and then Placebo single-dose. |
| Treatment D | Placebo comparator | Drug: TAS-303 9mg single-dose, Drug: Placebo 9mg single-doseTAS-303 Placebo single-dose and then TAS-303 9mg single-dose. |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patient has symptoms of Stress Urinary Incontinence (SUI) for at least 12 weeks prior to study entry
- Patient weights at least 45 kg and has body mass index (BMI) range of 18.0-30.0 kg/m2, inclusive, at screening
- Patient is positive in 1-hour pad weight test at screening
- Patient has at least 2 incontinence episodes per week.
Key exclusion criteria (5 listed)
- Patient has predominant or primary urge incontinence according to investigator judgment
- Patient had a prior surgical SUI treatment
- Patient is diagnosed Pelvic Organ Prolapse
- Patient is currently taking medication, or has taken medication in the last 4 weeks, for urinary incontinence or that effect urinary output function including anti-cholinergic or anti-histamines or any anti-anxiety medications.
- Patient is positive pregnancy test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAS-303 18mg single-dose | Drug | Treatment A, Treatment B |
| Placebo 18mg single-dose | Drug | Treatment A, Treatment B |
| TAS-303 9mg single-dose | Drug | Treatment C, Treatment D |
| Placebo 9mg single-dose | Drug | Treatment C, Treatment D |
Primary outcome
Change from baseline in Maximum Urethral Closure Pressure (MUCP)
Time frame: Baseline, 6 hours after the administration
6 secondary outcomes
Urethral pressure profile parameters: mean urethral closure pressure, functional profile length
Time frame: Baseline, 6 hours after the administration
Safety assessed by incidence and severity of adverse events
Time frame: Up to 36 days after the administration
Maximum plasma concentration (Cmax) of TAS-303
Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration
Time to maximum plasma concentration (tmax) of TAS-303
Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration
Area under the plasma concentration versus time curve (AUC) of TAS-303
Time frame: Immediately prior to dosing, and 1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration
Elimination half-time (t1/2) of TAS-303
Time frame: 1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taiho Pharmaceutical Co., Ltd. study director
Taiho Pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAS-303 18mg single-dose and TAS-303 9mg single-dose in people with Stress Urinary Incontinence, run by Taiho Pharmaceutical Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Maximum Urethral Closure Pressure (MUCP) (time frame: Baseline, 6 hours after the administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2016.