Overactive BladderNCT00786448
Post Marketing Surveillance Study on Emselex After Launch in Germany
An observational study of Overactive Bladder, run by Bayer at 1 site in Germany.
Trial summary
Data are obtained of Emselex in routine treatment of Overactive Bladder. The general objectives are to evaluate the product safety, compatibility, efficacy and patient acceptance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Darifenacin, Emselex (BAY79-4998)
- How many people
- 5,821 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2005to Feb 2006
- Phase
- Observational
- 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
Study population: Patients from routine practice
Who may be able to join
- Patients who are treated with Emselex for Overactive Bladder
Who cannot join
- Exclusion criteria are the contraindications as specified in the German product information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-Marketing Surveillance Study Emselex
- Data are obtained of Emselex in routine treatment of Overactive Bladder. The general objectives are to evaluate the product safety, compatibility, efficacy and patient acceptance.
- Conditions
- Overactive Bladder
- Being tested
- Darifenacin, Emselex (BAY79-4998)
- Keywords
- Overactive Bladder
- 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.
Darifenacin, Emselex (BAY79-4998)Drug
Patients from routine practice
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Darifenacin, Emselex (BAY79-4998) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events, Adverse drug reactions, physician's global assessment of tolerability
Measured: After 2-3 months of treatment (long-term 6 months)
Secondary outcomes (7)
Incontinence
Measured: At end of study
Urgency episodes
Measured: At end of study
Micturitions / nycturitions
Measured: At end of study
Physician's assessment of improvement/efficacy
Measured: At end of study
Physician's assessment of patient's satisfaction with therapeutic effect
Measured: At end of study
Physician's assessment of patient's ability to hold urine
Measured: At end of study
Dose and treatment duration of Emselex
Measured: At end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startJan 2005
- Primary completionFeb 2006
- Study completionFeb 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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,821 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786448
- Sponsor's protocol ID
- 12245
- Other IDs
- EX0501DE
- Status last verified
- Apr 2010
- First submitted
- 5 Nov 2008
- Last updated
- 30 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance Study Emselex
- ClinicalTrials.gov ID
- NCT00786448
- Acronym / sponsor ID
- 12245
- Conditions
- Overactive Bladder
- Keywords
- Overactive Bladder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,821 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 6 Nov 2008 (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.
- Data are obtained of Emselex in routine treatment of Overactive Bladder. The general objectives are to evaluate the product safety, compatibility, efficacy and patient acceptance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Darifenacin, Emselex (BAY79-4998) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from routine practice
Key inclusion criteria (1 listed)
- Patients who are treated with Emselex for Overactive Bladder
Key exclusion criteria (1 listed)
- Exclusion criteria are the contraindications as specified in the German product information
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, Emselex (BAY79-4998)Patients from routine practice | Drug | Group 1 |
Primary outcome
Adverse events, Adverse drug reactions, physician's global assessment of tolerability
Time frame: After 2-3 months of treatment (long-term 6 months)
7 secondary outcomes
Incontinence
Time frame: At end of study
Urgency episodes
Time frame: At end of study
Micturitions / nycturitions
Time frame: At end of study
Physician's assessment of improvement/efficacy
Time frame: At end of study
Physician's assessment of patient's satisfaction with therapeutic effect
Time frame: At end of study
Physician's assessment of patient's ability to hold urine
Time frame: At end of study
Dose and treatment duration of Emselex
Time frame: At end of study
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 30 Apr 2010.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder, run by Bayer at 1 site 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 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 30 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Adverse events, Adverse drug reactions, physician's global assessment of tolerability (time frame: After 2-3 months of treatment (long-term 6 months)). 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 30 Apr 2010.