Overactive BladderPhase 2BILADYNCT00564226
SSR240600C Treatment in Women With Overactive Bladder
A Phase 2 study testing SSR240600C and tolterodine in people with Overactive Bladder, run by Sanofi at 7 sites in 7 countries.
Trial summary
The primary objective of this study is to evaluate the efficacy of SSR240600C in women with overactive bladder compared to placebo using tolterodine as a study calibrator. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- SSR240600C and tolterodine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 345 participants
- Where
- 7 sitesin 7 countries
- Study dates
- Nov 2007to Feb 2009
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of overactive bladder
Who cannot join
- Stress incontinence or mixed incontinence where stress incontinence is the predominant component based on prior history
- Urinary incontinence due to cause other than detrusor overactivity (eg, overflow incontinence)
- Current Urinary Tract Infection (UTI) or frequent UTIs
- Urinary retention or other evidence of poor detrusor function
- Pain during voiding or bladder pain without voiding
- History of radiation cystitis or history of pelvic irradiation
- History of interstitial cystitis or bladder related pain syndrome
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
United States1 site
Sanofi-Aventis Aministrative Office
Bridgewater, New Jersey, 08807
About this study
Official title: A Placebo Controlled Randomized, 12-week, Dose-ranging, Double-blind Study Versus Placebo Using Tolterodine as a Study Calibrator, to Evaluate Efficacy and Safety of SSR240600C in Women With Overactive Bladder Including Urge Urinary Incontinence
The primary objective of this study is to evaluate the efficacy of SSR240600C in women with overactive bladder compared to placebo using tolterodine as a study calibrator.
- Conditions
- Overactive Bladder
- Being tested
- SSR240600C, tolterodine, placebo
- Keywords
- urge urinary incontinence
- 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.
SSR240600CDrug
oral administration
tolterodineDrug
oral administration
placeboDrug
oral administration
| Study group | Role | What they receive |
|---|---|---|
| SSR240600C Dose Level 1 | Experimental | Not described Receives: Drug: SSR240600C |
| SSR240600C Dose Level 2 | Experimental | Not described Receives: Drug: SSR240600C |
| SSR240600C Dose Level 3 | Experimental | dose level 3 Receives: Drug: SSR240600C |
| Tolterodine | Active comparator | Not described Receives: Drug: tolterodine |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the number of micturitions per 24 hours
Measured: at week 12
Secondary outcomes (3)
Changes from baseline in number of urge urinary incontinence episodes, in number of urgency episodes, in number of nocturia episodes, in volume of urine per void
Measured: at week 12
Safety of SSR240600C
Measured: at week 12
Quality of life
Measured: at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionFeb 2009
- Study completionFeb 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 SanofiThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00564226
- Sponsor's protocol ID
- DRI6271
- Other IDs
- EudraCT 2007-004126-24
- Acronym
- BILADY
- Status last verified
- Apr 2016
- First submitted
- 26 Nov 2007
- Last updated
- 26 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo Controlled Randomized, 12-week, Dose-ranging, Double-blind Study Versus Placebo Using Tolterodine as a Study Calibrator, to Evaluate Efficacy and Safety of SSR240600C in Women With Overactive Bladder Including Urge Urinary Incontinence
- ClinicalTrials.gov ID
- NCT00564226
- Acronym / sponsor ID
- BILADY / DRI6271
- Conditions
- Overactive Bladder
- Keywords
- urge urinary incontinence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 27 Nov 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 primary objective of this study is to evaluate the efficacy of SSR240600C in women with overactive bladder compared to placebo using tolterodine as a study calibrator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| SSR240600C Dose Level 1 | Experimental | Drug: SSR240600C |
| SSR240600C Dose Level 2 | Experimental | Drug: SSR240600C |
| SSR240600C Dose Level 3 | Experimental | Drug: SSR240600Cdose level 3 |
| Tolterodine | Active comparator | Drug: tolterodine |
| Placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of overactive bladder
Key exclusion criteria (8 listed)
- Stress incontinence or mixed incontinence where stress incontinence is the predominant component based on prior history
- Urinary incontinence due to cause other than detrusor overactivity (eg, overflow incontinence)
- Current Urinary Tract Infection (UTI) or frequent UTIs
- Urinary retention or other evidence of poor detrusor function
- Pain during voiding or bladder pain without voiding
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 |
|---|---|---|
| SSR240600Coral administration | Drug | SSR240600C Dose Level 1, SSR240600C Dose Level 2, SSR240600C Dose Level 3 |
| tolterodineoral administration | Drug | Tolterodine |
| placebooral administration | Drug | Placebo |
Primary outcome
Change from baseline in the number of micturitions per 24 hours
Time frame: at week 12
3 secondary outcomes
Changes from baseline in number of urge urinary incontinence episodes, in number of urgency episodes, in number of nocturia episodes, in volume of urine per void
Time frame: at week 12
Safety of SSR240600C
Time frame: at week 12
Quality of life
Time frame: at week 12
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 26 May 2016.
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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.
ICD CSD study director
Sanofi
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SSR240600C and tolterodine in people with Overactive Bladder, run by Sanofi at 7 sites in 7 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 8 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 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada, Czechia, France, Germany and 2 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?
Change from baseline in the number of micturitions per 24 hours (time frame: at week 12). 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 26 May 2016.