Multiple SclerosisPhase 2NCT00845338
Study of Darifenacin in Patients Suffering From Multiple Sclerosis and Neurogenic Detrusor Overactivity
A Phase 2 study testing Darifenacin (BAY79-4998) in people with Multiple Sclerosis and Overactive Detrusor, run by Bayer at 15 sites in Germany.
Trial summary
The objective of this study is to explore the effects of darifenacin in patients with multiple sclerosis and neurogenic detrusor overactivity. The efficacy, safety and tolerability of darifenacin are already well established in idiopathic detrusor overactivity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Overactive Detrusor
- What is being tested?
- Darifenacin (BAY79-4998)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 15 sitesGermany
- Study dates
- Feb 2007to Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with multiple sclerosis for at least 6 months
- Neurogenic detrusor overactivity without DSD
- Symptoms of OAB
- Patients capable of completing the bladder diary
- Patients capable of independent toileting
- Patients able to swallow the study medication in accordance to the protocol
- Body Mass Index >/= 18,8 kg/qm and </= 35,0 kg/qm
- documented, dated, written informed consent
Who cannot join
- Treatment with drugs known to affect mainly the urinary function 14 days prior to starting completion of the baseline diary for Visit 2
- Participation in a bladder-training program
- Low compliance bladder (Compliance <20 mL/cm H2O)
- DSD, Detrusor hyporeflexia / areflexia and bradykinesia / tremor of the external urethral sphincter
- Indwelling catheter or intermittent self-catheterization
- Patience with post-void residual (PVR) urinary volume > 200 mL at baseline
Show all 11Show fewer
- Urinary retention or clinically significant bladder outlet obstruction as detected by the investigator
- Clinically predominant and bothersome stress urinary incontinence
- Neurological diseases other than multiple sclerosis affecting urinary bladder function
- Any urogenital surgery within 12 month prior to Visit 1
- 17 Additional Exclusion Criteria
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Germany15 sites
Study site
Bad Berka, Thuringia, 99437
Study site
Berlin, State of Berlin, 10115
Study site
Emmendingen, Baden-Wurttemberg, 79312
Study site
Halle, Saxony-Anhalt, 06112
Study site
Hamburg, Free and Hanseatic City of Hamburg, 20246
Study site
Heidelberg, Baden-Wurttemberg, 69112
Study site
Herne, North Rhine-Westphalia, 44627
Study site
Lahr, Baden-Wurttemberg, 77933
Study site
Mainz, Rhineland-Palatinate, 55131
Study site
Mönchengladbach, North Rhine-Westphalia, 41063
Study site
Mülheim, North Rhine-Westphalia, 45468
Study site
Oberursel, Hesse, 61440
Study site
Planegg, Bavaria, 82152
Study site
Tübingen, Baden-Wurttemberg, 72076
Study site
Villingen-Schwenningen, Baden-Wurttemberg, 78054
About this study
Official title: A 4-week, Open-label, Multicenter, Urodynamic Pilot Study to Explore the Efficacy, Tolerability and Safety of Darifenacin (7.5 mg With Up-titration to 15 mg) in Patients With Multiple Sclerosis and Neurogenic Detrusor Overactivity
The objective of this study is to explore the effects of darifenacin in patients with multiple sclerosis and neurogenic detrusor overactivity. The efficacy, safety and tolerability of darifenacin are already well established in idiopathic detrusor overactivity. Patients with multiple sclerosis and neurogenic detrusor overactivity without detrusor-sphincter-dyssynergia (DSD) will be allocated to darifenacin therapy.
- Conditions
- Multiple Sclerosis, Overactive Detrusor
- Being tested
- Darifenacin (BAY79-4998)
- Keywords
- Darifenacin, Multiple Sclerosis, Open Label Study
- Medical subject headings
- Multiple Sclerosis, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darifenacin (BAY79-4998)Drug
Darifenacin 7,5mg tablets once daily for 14 days, darifenacin 7,5mg or 15mg once daily for 14 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Darifenacin (BAY79-4998) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in volume at first detrusor contraction as determined by urodynamics
Measured: At week 4
Secondary outcomes (8)
Detrusor pressure at first contraction
Measured: At week 4
Volume at first detectable leakage
Measured: At week 4
Volume at 10/20/30/40 cm H2O
Measured: At week 4
Compliance
Measured: At week 4
Maximum cystometric bladder capacity
Measured: At week 4
7-day micturition diary: Micturitions
Measured: At days 0, 14, 28
7-day micturition diary: Urgency episodes
Measured: At days 0, 14, 28
7-day micturition diary: Urge urinary incontinence episodes
Measured: At days 0, 14, 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startFeb 2007
- Primary completionOct 2007
- Study completionOct 2007
Why it stopped: The enrollment rate at most centers was unlikely to result in the recruitment of the planned sample size of 40 evaluable subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845338
- Sponsor's protocol ID
- 12331
- Other IDs
- 2006-002361-39
- Status last verified
- Nov 2014
- First submitted
- 16 Feb 2009
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-week, Open-label, Multicenter, Urodynamic Pilot Study to Explore the Efficacy, Tolerability and Safety of Darifenacin (7.5 mg With Up-titration to 15 mg) in Patients With Multiple Sclerosis and Neurogenic Detrusor Overactivity
- ClinicalTrials.gov ID
- NCT00845338
- Acronym / sponsor ID
- 12331
- Conditions
- Multiple Sclerosis, Overactive Detrusor
- Keywords
- Darifenacin, Multiple Sclerosis, Open Label Study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The enrollment rate at most centers was unlikely to result in the recruitment of the planned sample size of 40 evaluable subjects.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 18 Feb 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 explore the effects of darifenacin in patients with multiple sclerosis and neurogenic detrusor overactivity. The efficacy, safety and tolerability of darifenacin are already well established in idiopathic detrusor overactivity. Patients with multiple sclerosis and neurogenic detrusor overactivity without detrusor-sphincter-dyssynergia (DSD) will be allocated to darifenacin therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Darifenacin (BAY79-4998) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with multiple sclerosis for at least 6 months
- Neurogenic detrusor overactivity without DSD
- Symptoms of OAB
- Patients capable of completing the bladder diary
- Patients capable of independent toileting
Key exclusion criteria (11 listed)
- Treatment with drugs known to affect mainly the urinary function 14 days prior to starting completion of the baseline diary for Visit 2
- Participation in a bladder-training program
- Low compliance bladder (Compliance <20 mL/cm H2O)
- DSD, Detrusor hyporeflexia / areflexia and bradykinesia / tremor of the external urethral sphincter
- Indwelling catheter or intermittent self-catheterization
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 |
|---|---|---|
| Darifenacin (BAY79-4998)Darifenacin 7,5mg tablets once daily for 14 days, darifenacin 7,5mg or 15mg once daily for 14 consecutive days | Drug | Arm 1 |
Primary outcome
Change from baseline in volume at first detrusor contraction as determined by urodynamics
Time frame: At week 4
8 secondary outcomes
Detrusor pressure at first contraction
Time frame: At week 4
Volume at first detectable leakage
Time frame: At week 4
Volume at 10/20/30/40 cm H2O
Time frame: At week 4
Compliance
Time frame: At week 4
Maximum cystometric bladder capacity
Time frame: At week 4
7-day micturition diary: Micturitions
Time frame: At days 0, 14, 28
7-day micturition diary: Urgency episodes
Time frame: At days 0, 14, 28
7-day micturition diary: Urge urinary incontinence episodes
Time frame: At days 0, 14, 28
Results and safety
The study was stopped early (reason given: The enrollment rate at most centers was unlikely to result in the recruitment of the planned sample size of 40 evaluable subjects.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
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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.
Bayer Study Director study director
Bayer
15 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 Darifenacin (BAY79-4998) in people with Multiple Sclerosis and Overactive Detrusor, run by Bayer at 15 sites in Germany.
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 8 inclusion and 11 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: stopped early, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany. 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. 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 was stopped early (reason given: The enrollment rate at most centers was unlikely to result in the recruitment of the planned sample size of 40 evaluable subjects.). Results are not available in the source record.
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 volume at first detrusor contraction as determined by urodynamics (time frame: At week 4). 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 Dec 2014.