Overactive BladderPhase 2NCT00174798
MILADY: A Randomized, Placebo-controlled Safety and Efficacy Trial of SSR240600C in Treatment of Overactive Bladder or Urge Urinary Incontinence.
A Phase 2 study testing SSR240600C and Tolterodine in people with Overactive Bladder, run by Sanofi at 22 sites in United States.
Trial summary
To evaluate the safety and efficacy of SSR240600C versus placebo on clinical and cystometric parameters in patients with OAB and UUI. Read more about this study
- Who is it for?
- Ages 18 to 75 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
- 118 participants
- Where
- 22 sitesUnited States
- Study dates
- May 2005to May 2006
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females between 18 and 75 years, inclusive Clinical diagnosis of OAB/UUI (symptoms of frequent micturition, urinary urgency)
- Bladder capacity </= 300 mL by cystometry
Who cannot join
- History of interstitial cystitis, bladder outlet obstruction or other significant genitourinary disorder
- Current urinary tract infection
- Neurological bladder dysfunction
- Treatment with drugs that may interfere with CYP3A4 metabolic function
- History of stress urinary incontinence
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Atlanta Women's Research Institute
Alpharetta, Georgia, 30005
Mount Vernon Clinical Research
Atlanta, Georgia, 30328
Advanced Research Associates
Corpus Christi, Texas, 78414
Soapstone Center for Education & Clinical Research
Decatur, Georgia, 30034
Genitourinary Surgical Consultants
Denver, Colorado, 80220
Urology of Indiana
Greenwood, Indiana, 46143
Metropolitan Urology
Jeffersonville, Indiana, 47130
Rockhill Medical Plaza
Kansas City, Missouri, 64131
Hudson Valley Urology Center
Kingston, New York, 12401
Daniel Laury
Medford, Oregon, 97504
Miami Research Associates
Miami, Florida, 33143
Midwest Research SpecialistsSt. Michael's Hospital
Milwaukee, Wisconsin, 53209
Philadelphia Women's Research
Philadelphia, Pennsylvania, 19114
Hope Research LLC
Phoenix, Arizona, 85032
Clinical Trials Research Services
Pittsburgh, Pennsylvania, 15206
Hudson Valley Urology
Poughkeepsie, New York, 12601
University Urological Research Institute
Providence, Rhode Island, 02904
Medical Center for Clinical Research
San Diego, California, 92108
Tacoma Women's Specialists Research
Tacoma, Washington, 98405
Southeastern Research Group
Tallahassee, Florida, 32308
Research Tuscon
Tuscon, Arizona, 85712
Connecticut Clinical Research Center, Urology Specialists
Waterbury, Connecticut, 06708
About this study
Official title: A Randomized, Double-blind, Placebo and Active-controlled Efficacy and Safety Study of SSR240600C in Patients With Overactive Bladder (OAB) or Urge Urinary Incontinence (UUI)
To evaluate the safety and efficacy of SSR240600C versus placebo on clinical and cystometric parameters in patients with OAB and UUI.
Read the detailed description
Prospective, randomized, parallel group, double-dummy, placebo and active-controlled (Detrol LA - tolterodine) trial wherein patients with OAB or UUI will receive single daily does of either SSR240600C 500 mg, tolterodine 4 mg or placebo for four weeks. Baseline and end of study cystometry will be performed; daily symptom diaries will be completed during the trial and health-related quality of life will be measured before and after study drug treatment. Patients will be followed-up one week after completion of the trial. Study participation will include 5 visits over a period of six weeks.
- Conditions
- Overactive Bladder
- Being tested
- SSR240600C, Placebo, Tolterodine
- Keywords
- Cystometry NK1 Antagonist SSR240600C
- 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.
SSR240600CDrug
once daily
PlaceboDrug
oral
TolterodineDrug
once daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| SSR240600C | Experimental | Not described Receives: Drug: SSR240600C |
| Tolterodine | Active comparator | Not described Receives: Drug: Tolterodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bladder capacity as determined by cystometric parameters from baseline to end of treatment.
Secondary outcomes (1)
Change from baseline to end of treatment in:maximum detrusor pressure,volume ar first desire to void,volume at first unstable contraction,micturition frequence,urgency episodes,nocturia episodes,incontinence episodes,HRQOL and overall improvement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionMay 2006
- Study completionMay 2006
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
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00174798
- Sponsor's protocol ID
- ACT5190
- Other IDs
- SSR240600C
- Status last verified
- Feb 2012
- First submitted
- 13 Sep 2005
- Last updated
- 2 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo and Active-controlled Efficacy and Safety Study of SSR240600C in Patients With Overactive Bladder (OAB) or Urge Urinary Incontinence (UUI)
- ClinicalTrials.gov ID
- NCT00174798
- Acronym / sponsor ID
- ACT5190
- Conditions
- Overactive Bladder
- Keywords
- Cystometry NK1 Antagonist SSR240600C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 15 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.
To evaluate the safety and efficacy of SSR240600C versus placebo on clinical and cystometric parameters in patients with OAB and UUI.
Detailed description
Prospective, randomized, parallel group, double-dummy, placebo and active-controlled (Detrol LA - tolterodine) trial wherein patients with OAB or UUI will receive single daily does of either SSR240600C 500 mg, tolterodine 4 mg or placebo for four weeks. Baseline and end of study cystometry will be performed; daily symptom diaries will be completed during the trial and health-related quality of life will be measured before and after study drug treatment. Patients will be followed-up one week after completion of the trial. Study participation will include 5 visits over a period of six weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| SSR240600C | Experimental | Drug: SSR240600C |
| Tolterodine | Active comparator | Drug: Tolterodine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Females between 18 and 75 years, inclusive Clinical diagnosis of OAB/UUI (symptoms of frequent micturition, urinary urgency)
- Bladder capacity </= 300 mL by cystometry
Key exclusion criteria (5 listed)
- History of interstitial cystitis, bladder outlet obstruction or other significant genitourinary disorder
- Current urinary tract infection
- Neurological bladder dysfunction
- Treatment with drugs that may interfere with CYP3A4 metabolic function
- History of stress urinary incontinence
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 |
|---|---|---|
| SSR240600Conce daily | Drug | SSR240600C |
| Placebooral | Drug | Placebo |
| Tolterodineonce daily | Drug | Tolterodine |
Primary outcome
Change in bladder capacity as determined by cystometric parameters from baseline to end of treatment.
1 secondary outcome
Change from baseline to end of treatment in:maximum detrusor pressure,volume ar first desire to void,volume at first unstable contraction,micturition frequence,urgency episodes,nocturia episodes,incontinence episodes,HRQOL and overall improvement
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 2 Feb 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.
Clinical Sciences & Operations study director
Sanofi
22 sites in 1 country: 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 22 sites in United States.
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 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 2 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. 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 in bladder capacity as determined by cystometric parameters from baseline to end of treatment.. 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 2 Feb 2012.