Overactive BladderPhase 3NCT01004315
A Confirmatory Study of KUC-7483 in Patients With Overactive Bladder
A Phase 3 study testing KUC-7483 and Tolterodine in people with Overactive Bladder, run by Kissei Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
To evaluate the efficacy and the safety of KUC-7483 in overactive bladder patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- KUC-7483 and Tolterodine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 750 participants
- Where
- 1 siteJapan
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a symptom of overactive bladder for more than 6 months.
- Patients who meet the following condition during the 3-day bladder diary period.
- the mean number of micturitions per 24 hours is ≥8 times
- the mean number of urgency episodes per 24 hours is ≥1 time
Who cannot join
- Patients who are diagnosed as stress urinary incontinence are predominant.
- Patients with urinary calculus, interstitial cystitis, or clinically significant urinary tract infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double Blind, Placebo Controlled, Phase III Study of KUC-7483 in Patients With Overactive Bladder
To evaluate the efficacy and the safety of KUC-7483 in overactive bladder patients.
- Conditions
- Overactive Bladder
- Being tested
- KUC-7483, Placebo, Tolterodine
- Keywords
- Overactive bladder, Frequency, Micturition, Urgency, Urge urinary incontinence, OAB
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KUC-7483Drug
PlaceboDrug
TolterodineDrug
| Study group | Role | What they receive |
|---|---|---|
| KUC-7483 | Experimental | Not described Receives: Drug: KUC-7483 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Tolterodine | Active comparator | Not described Receives: Drug: Tolterodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the mean number of micturitions per 24 hours
Measured: 12 weeks
Secondary outcomes (2)
Change from baseline in the mean number of urgency episodes per 24 hours
Measured: 12 weeks
Change from baseline in the mean number of incontinence episodes per 24 hours
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yasuhiro Omori, Study director, Clinical Development Department, Kissei pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01004315
- Sponsor's protocol ID
- KUC1301
- Status last verified
- Jul 2010
- First submitted
- 27 Oct 2009
- Last updated
- 27 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled, Phase III Study of KUC-7483 in Patients With Overactive Bladder
- ClinicalTrials.gov ID
- NCT01004315
- Acronym / sponsor ID
- KUC1301
- Conditions
- Overactive Bladder
- Keywords
- Overactive bladder, Frequency, Micturition, Urgency, Urge urinary incontinence, OAB
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Kissei Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- First posted
- 29 Oct 2009 (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.
To evaluate the efficacy and the safety of KUC-7483 in overactive bladder patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| KUC-7483 | Experimental | Drug: KUC-7483 |
| Placebo | Placebo comparator | Drug: Placebo |
| Tolterodine | Active comparator | Drug: Tolterodine |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a symptom of overactive bladder for more than 6 months.
- Patients who meet the following condition during the 3-day bladder diary period.
Key exclusion criteria (2 listed)
- Patients who are diagnosed as stress urinary incontinence are predominant.
- Patients with urinary calculus, interstitial cystitis, or clinically significant urinary tract infection.
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 |
|---|---|---|
| KUC-7483 | Drug | KUC-7483 |
| Placebo | Drug | Placebo |
| Tolterodine | Drug | Tolterodine |
Primary outcome
Change from baseline in the mean number of micturitions per 24 hours
Time frame: 12 weeks
2 secondary outcomes
Change from baseline in the mean number of urgency episodes per 24 hours
Time frame: 12 weeks
Change from baseline in the mean number of incontinence episodes per 24 hours
Time frame: 12 weeks
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 27 Jul 2010.
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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.
Yasuhiro Omori study director
Clinical Development Department, Kissei 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 3 study testing KUC-7483 and Tolterodine in people with Overactive Bladder, run by Kissei 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 2 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 27 Jul 2010. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 the mean number of micturitions per 24 hours (time frame: 12 weeks). 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 27 Jul 2010.