Overactive BladderPhase 3NCT00212732
Controlled Study of ONO-8025 (KRP-197) in Patients With Overactive Bladder in Japan
A Phase 3 study testing ONO-8025 (KRP-197) in people with Overactive Bladder, run by Ono Pharmaceutical Co., Ltd..
Trial summary
The purpose of this study is to evaluate the efficacy and safety of ONO-8025 (KRP-197) in patients with overactive bladder. 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?
- ONO-8025 (KRP-197)
- How many people
- 750 participants
- Where
- No sites listed yet
- Study dates
- Oct 2003to Apr 2006
- 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 who are 20 years old or over with overactive bladder
- Total number of urinary incontinence episodes per week is 5 or over
- Mean number of micturition per day is 8 or over
- Mean number of urinary urgency episodes per day is 1 or over
- Other inclusion criteria as specified in the study protocol
Who cannot join
- Patients with genuine stress incontinence
- Patients suffering from complications such as bladder tumor, bladder stone and urinary tract infection
- Patients who have undergone surgical operation of urinary and/or genital organs within 6 months prior to the study
- Patients suffering from complications for which anticholinergics are contraindicated
- Other exlcusion criteria as specified in the study protocol
About this study
The purpose of this study is to evaluate the efficacy and safety of ONO-8025 (KRP-197) in patients with overactive bladder.
- Conditions
- Overactive Bladder
- Being tested
- ONO-8025 (KRP-197)
- Keywords
- ONO-8025, KRP-197, 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.
ONO-8025 (KRP-197)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of urinary incontinence episodes per week
Secondary outcomes (1)
Number of micturition per day, number of urinary urgency episodes per day, volume voided per micturition and QOL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startOct 2003
- Primary completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 750 participants
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Project Leader, Development Planning, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212732
- Sponsor's protocol ID
- ONO-8025-08
- Status last verified
- Oct 2012
- First submitted
- 13 Sep 2005
- Last updated
- 11 Oct 2012
- Results posted
- No
Publications
Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
PubMed 37160401
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Study of ONO-8025 (KRP-197) in Patients With Overactive Bladder in Japan
- ClinicalTrials.gov ID
- NCT00212732
- Acronym / sponsor ID
- ONO-8025-08
- Conditions
- Overactive Bladder
- Keywords
- ONO-8025, KRP-197, overactive bladder, antimuscarinic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Apr 2006 (actual)
- First posted
- 21 Sep 2005 (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 efficacy and safety of ONO-8025 (KRP-197) in patients with overactive bladder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who are 20 years old or over with overactive bladder
- Total number of urinary incontinence episodes per week is 5 or over
- Mean number of micturition per day is 8 or over
- Mean number of urinary urgency episodes per day is 1 or over
- Other inclusion criteria as specified in the study protocol
Key exclusion criteria (5 listed)
- Patients with genuine stress incontinence
- Patients suffering from complications such as bladder tumor, bladder stone and urinary tract infection
- Patients who have undergone surgical operation of urinary and/or genital organs within 6 months prior to the study
- Patients suffering from complications for which anticholinergics are contraindicated
- Other exlcusion criteria as specified in the study protocol
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 |
|---|---|---|
| ONO-8025 (KRP-197) | Drug | – |
Primary outcome
Total number of urinary incontinence episodes per week
1 secondary outcome
Number of micturition per day, number of urinary urgency episodes per day, volume voided per micturition and QOL
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 11 Oct 2012.
- Derived from this study: PubMed 37160401Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
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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.
Project Leader, Development Planning study director
Ono Pharmaceutical Co., Ltd.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ONO-8025 (KRP-197) in people with Overactive Bladder, run by Ono Pharmaceutical Co., Ltd..
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 5 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 11 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Total number of urinary incontinence episodes per week. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00212732, which also lists 1 linked publication.
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 11 Oct 2012.