Overactive BladderPhase 3NCT00512785
Long-term Safety and Efficacy of Imidafenacin in Patients With Overactive Bladder
A Phase 3 study testing imidafenacin, KRP-197/ONO-8025 in people with Overactive Bladder, run by Ono Pharmaceutical Co., Ltd. at 2 sites in Japan.
Trial summary
The purpose of this study is to evaluate the long-term safety and efficacy of imidafenacin. 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?
- imidafenacin, KRP-197/ONO-8025
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 435 participants
- Where
- 2 sitesJapan
- Study dates
- Aug 2007to May 2009
- 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
- Men and Woman equal or > 20 years old
- Patients with urgency, urinary frequency and urgency incontinence
Who cannot join
- Patients with genuine stress incontinence
- Patients suffering from complications such as bladder tumor, urinary tract stone and symptomatic urinary tract infection
- Patients suffering from complications contraindicating the use of antimuscarinic medication
- Patients with polyuria
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: An Open-label Study to Evaluate the Long-term Safety and Efficacy of Imidafenacin in Patients With Overactive Bladder
The purpose of this study is to evaluate the long-term safety and efficacy of imidafenacin.
- Conditions
- Overactive Bladder
- Being tested
- imidafenacin, KRP-197/ONO-8025
- Keywords
- Imidafenacin, KRP-197/ONO-8025, overactive bladder, antimuscarinic
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imidafenacin, KRP-197/ONO-8025Drug
0.1 mg BID for 52 weeks
imidafenacin, KRP-197/ONO-8025Drug
0.1 mg BID for 12 weeks and 0.2 mg BID for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| E1 | Experimental | Not described Receives: Drug: imidafenacin, KRP-197/ONO-8025 |
| E2 | Experimental | Not described Receives: Drug: imidafenacin, KRP-197/ONO-8025 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Measures: adverse events, laboratory tests, 12-lead ECG, vital signs, post-void residual volume
Measured: 64 weeks
Secondary outcomes (1)
Efficacy measures: number of urgency incontinence episodes per week, number of incontinence episodes per week, number of micturitions per day, number of urgency episodes per day, severity of urgency, urine volume voided per micturition, Quality of Life
Measured: 64 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionMay 2009
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.
- More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 435 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kyorin Pharmaceutical Co.,Ltd
- Responsible party
- Sponsor
- Investigators
- Yoshifumi Hirahara, Study director, Kyorin Pharmaceutical Co.,LtdToshihiko Konomi, Study chair, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512785
- Sponsor's protocol ID
- KRP197-T301/ONO-8025-12
- Status last verified
- Jun 2012
- First submitted
- 7 Aug 2007
- Last updated
- 13 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Evaluate the Long-term Safety and Efficacy of Imidafenacin in Patients With Overactive Bladder
- ClinicalTrials.gov ID
- NCT00512785
- Acronym / sponsor ID
- KRP197-T301/ONO-8025-12
- Conditions
- Overactive Bladder
- Keywords
- Imidafenacin, KRP-197/ONO-8025, overactive bladder, antimuscarinic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 435 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Kyorin Pharmaceutical Co.,Ltd
- Study start
- Aug 2007
- Primary completion
- May 2009 (actual)
- First posted
- 8 Aug 2007 (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 the long-term safety and efficacy of imidafenacin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E1 | Experimental | Drug: imidafenacin, KRP-197/ONO-8025 |
| E2 | Experimental | Drug: imidafenacin, KRP-197/ONO-8025 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and Woman equal or > 20 years old
- Patients with urgency, urinary frequency and urgency incontinence
Key exclusion criteria (4 listed)
- Patients with genuine stress incontinence
- Patients suffering from complications such as bladder tumor, urinary tract stone and symptomatic urinary tract infection
- Patients suffering from complications contraindicating the use of antimuscarinic medication
- Patients with polyuria
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 |
|---|---|---|
| imidafenacin, KRP-197/ONO-80250.1 mg BID for 52 weeks | Drug | E1 |
| imidafenacin, KRP-197/ONO-80250.1 mg BID for 12 weeks and 0.2 mg BID for 52 weeks | Drug | E2 |
Primary outcome
Safety Measures: adverse events, laboratory tests, 12-lead ECG, vital signs, post-void residual volume
Time frame: 64 weeks
1 secondary outcome
Efficacy measures: number of urgency incontinence episodes per week, number of incontinence episodes per week, number of micturitions per day, number of urgency episodes per day, severity of urgency, urine volume voided per micturition, Quality of Life
Time frame: 64 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 13 Jun 2012.
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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.
Yoshifumi Hirahara study director
Kyorin Pharmaceutical Co.,Ltd
Toshihiko Konomi study chair
Ono Pharmaceutical Co., Ltd.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing imidafenacin, KRP-197/ONO-8025 in people with Overactive Bladder, run by Ono Pharmaceutical Co., Ltd. at 2 sites 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 2 inclusion and 4 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 13 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Safety Measures: adverse events, laboratory tests, 12-lead ECG, vital signs, post-void residual volume (time frame: 64 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 13 Jun 2012.