Overactive Bladder (OAB)Phase 2NCT00507169
SVT-40776 in Patients Suffering From Overactive Bladder Syndrome
A Phase 2 study testing SVT-40776 in people with Overactive Bladder (OAB), run by Salvat.
Trial summary
The study will examine which dose of SVT-40776 is best in terms of efficacy, safety and tolerability compared to placebo and tolterodine Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Overactive Bladder (OAB)
- What is being tested?
- SVT-40776
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 2006to Sep 2007
- 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 suffering from OAB for at least 6 months prior to inclusion
Who cannot join
- Pregnant and breastfeeding women
- Any medical condition or need for co-medication which interferes with the drug under investigation (SVT-40776) or the comparator (tolterodine)
About this study
The study will examine which dose of SVT-40776 is best in terms of efficacy, safety and tolerability compared to placebo and tolterodine
- Conditions
- Overactive Bladder (OAB)
- Being tested
- SVT-40776
- 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.
SVT-40776Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2007 (estimated)
- Study startSep 2006
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder (OAB)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Salvat
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00507169
- Sponsor's protocol ID
- 40776ORII/05IA01
- Status last verified
- Jun 2011
- First submitted
- 25 Jul 2007
- Last updated
- 8 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SVT-40776 in Patients Suffering From Overactive Bladder Syndrome
- ClinicalTrials.gov ID
- NCT00507169
- Acronym / sponsor ID
- 40776ORII/05IA01
- Conditions
- Overactive Bladder (OAB)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- SalvatIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 26 Jul 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 study will examine which dose of SVT-40776 is best in terms of efficacy, safety and tolerability compared to placebo and tolterodine
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
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 suffering from OAB for at least 6 months prior to inclusion
Key exclusion criteria (2 listed)
- Pregnant and breastfeeding women
- Any medical condition or need for co-medication which interferes with the drug under investigation (SVT-40776) or the comparator (tolterodine)
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 |
|---|---|---|
| SVT-40776 | Drug | – |
Primary outcome
Not reported in the source record.
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 8 Jun 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SVT-40776 in people with Overactive Bladder (OAB), run by Salvat.
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 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 8 Jun 2011. 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 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.
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 8 Jun 2011.