Overactive BladderPhase 2NCT00876421
Study of ONO-8539 in Patients With Overactive Bladder
A Phase 2 study testing Tolterodine and ONO-8539 in people with Overactive Bladder, run by Ono Pharmaceutical Co., Ltd. at 50 sites in 9 countries.
Trial summary
The objective of this study is to investigate efficacy, safety and tolerability of ONO-8539 in patients with overactive bladder. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Tolterodine and ONO-8539
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 435 participants
- Where
- 50 sitesin 9 countries
- Study dates
- Apr 2009to Apr 2010
- Phase
- Phase 2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with medical history of Overactive Bladder symptoms for > 6 months
Who cannot join
- Patients who have a history or presence of other significant diseases, which in the opinion of the investigator, might compromise the patient's safety or the evaluation of the study results
Trial locations and contacts
50 sites in 9 countries.
50 sites in 9 countries
Poland9 sites
Study site
Bialystok
Study site
Bielsko-Biala
Study site
Gdansk
Study site
Gdynia
Study site
Katowice
Study site
Lodz
Study site
Lublin
Study site
Mysłowice
Study site
Warsaw
Czechia8 sites
Study site
Brno
Study site
Jindřichův Hradec
Study site
Olomouc
Study site
Opava
Study site
Pilsen
Study site
Prague
Study site
Štětí
Study site
Ústí nad Labem
Germany6 sites
Study site
Duisburg
Study site
Hagenow
Study site
Krumbach
Study site
Magdeburg
Study site
Mülheim
Study site
Weiden
Hungary5 sites
Study site
Budapest
Study site
Dombóvár
Study site
Nyíregyháza
Study site
Szeged
Study site
Szekszárd
Netherlands5 sites
Study site
Heerlen
Study site
Maastricht
Study site
The Hague
Study site
Tilburg
Study site
Winterswijk
Sweden5 sites
Study site
Gothenburg
Study site
Kungälv
Study site
Stockholm
Study site
Umeå
Study site
Uppsala
Ukraine5 sites
Study site
Chernivtsi
Study site
Donetsk
Study site
Kharkiv
Study site
Kyiv
Study site
Zaporizhzhya
Romania4 sites
Study site
Arad
Study site
Bihor
Study site
Bucharest
Study site
Timuș
Russia3 sites
Study site
Moscow
Study site
Rostov-on-Don
Study site
Saint Petersburg
About this study
Official title: A Randomised, Multi-Centre, Double-Blind, Placebo and Active-Controlled, 5-Way Parallel Group Study to Investigate the Efficacy, Safety and Tolerability of ONO-8539 in Patients With Overactive Bladder
The objective of this study is to investigate efficacy, safety and tolerability of ONO-8539 in patients with overactive bladder.
- Conditions
- Overactive Bladder
- Being tested
- Placebo, Tolterodine, ONO-8539
- Keywords
- ONO-8539, Overactive bladder, OAB
- 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.
PlaceboDrug
Placebo / 12 weeks
TolterodineDrug
4mg / 12 weeks
ONO-8539Drug
low dose / 12 weeks
ONO-8539Drug
medium dose / 12 weeks
ONO-8539Drug
higher dose / 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| P | Placebo comparator | Not described Receives: Drug: Placebo |
| A | Active comparator | Not described Receives: Drug: Tolterodine |
| E1 | Experimental | Not described Receives: Drug: ONO-8539 |
| E2 | Experimental | Not described Receives: Drug: ONO-8539 |
| E3 | Experimental | Not described Receives: Drug: ONO-8539 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overactive bladder symptoms
Measured: 12 weeks
Secondary outcomes (1)
Overactive bladder symptoms (QOL)
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 posted6 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2010
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 435 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tomohiro Kuwayama, Study director, Clinical Development, ONO Pharma UK, Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876421
- Sponsor's protocol ID
- ONO-8539POE004
- Status last verified
- Jun 2012
- First submitted
- 2 Apr 2009
- Last updated
- 14 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Multi-Centre, Double-Blind, Placebo and Active-Controlled, 5-Way Parallel Group Study to Investigate the Efficacy, Safety and Tolerability of ONO-8539 in Patients With Overactive Bladder
- ClinicalTrials.gov ID
- NCT00876421
- Acronym / sponsor ID
- ONO-8539POE004
- Conditions
- Overactive Bladder
- Keywords
- ONO-8539, Overactive bladder, OAB
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 435 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Apr 2010 (actual)
- First posted
- 6 Apr 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.
The objective of this study is to investigate efficacy, safety and tolerability of ONO-8539 in patients with overactive bladder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| P | Placebo comparator | Drug: Placebo |
| A | Active comparator | Drug: Tolterodine |
| E1 | Experimental | Drug: ONO-8539 |
| E2 | Experimental | Drug: ONO-8539 |
| E3 | Experimental | Drug: ONO-8539 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with medical history of Overactive Bladder symptoms for > 6 months
Key exclusion criteria (1 listed)
- Patients who have a history or presence of other significant diseases, which in the opinion of the investigator, might compromise the patient's safety or the evaluation of the study results
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 |
|---|---|---|
| PlaceboPlacebo / 12 weeks | Drug | P |
| Tolterodine4mg / 12 weeks | Drug | A |
| ONO-8539low dose / 12 weeks | Drug | E1 |
| ONO-8539medium dose / 12 weeks | Drug | E2 |
| ONO-8539higher dose / 12 weeks | Drug | E3 |
Primary outcome
Overactive bladder symptoms
Time frame: 12 weeks
1 secondary outcome
Overactive bladder symptoms (QOL)
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 14 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.
Tomohiro Kuwayama study director
Clinical Development, ONO Pharma UK, Ltd
50 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tolterodine and ONO-8539 in people with Overactive Bladder, run by Ono Pharmaceutical Co., Ltd. at 50 sites in 9 countries.
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 1 inclusion and 1 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 14 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 50 sites in Poland, Czechia, Germany, Hungary, Netherlands and 4 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Overactive bladder symptoms (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 14 Jun 2012; AzTrials last refreshed its copy on 6 Nov 2026.