Overactive BladderPhase 2NCT00439192
ELB245 for 12 Weeks Versus 4mg Tolterodine in Patients With Incontinent Overactive Bladder (OAB)
A Phase 2 study testing ELB245 and Tolterodine in people with Overactive Bladder and Urinary Incontinence, run by elbion AG at 31 sites in 3 countries.
Trial summary
This study is designed to determine the efficacy of escalating doses of ELB245 versus placebo , when administered to patients with OAB and to compare the efficacy of escalating doses of ELB245 versus the standard treatment tolterodine, when administered to patients with OAB. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder, Urinary Incontinence
- What is being tested?
- ELB245 and Tolterodine
- How many people
- 275 participants
- Where
- 31 sitesin 3 countries
- Study dates
- Feb 2007to Aug 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
- Male or female outpatients at least 18 years of age
- Symptoms of OAB for a minimum of 3 consecutive months prior to study entry; severity of OAB (as defined by patient reported symptoms) for a minimum of one month prior to study entry
- Ability to use a toilet independently and without difficulty
- No treatment with any medication against OAB during the 4 weeks prior to study entry
- Written informed consent
Who cannot join
- Breastfeeding women, pregnant women or women who intend to become pregnant during the study or women of childbearing potential who are sexually active and not practicing a highly reliable method of birth control
- Any local pathology, that might cause the bladder symptoms
- Significant stress urinary incontinence or mixed stress/urgency incontinence
- Any neurological disease affecting bladder function or muscle strength
- Patient history of any lower urinary tract surgery or previous pelvic irradiation
- Local administration of botulinum toxin within the last 9 months in the lower urinary tract
Show all 20Show fewer
- Start or change of a behavioral bladder training program
- Post voiding residual volumes larger than 250ml or symptoms of clinically relevant bladder outlet obstruction
- Nocturial polyuria
- History of liver disease and/or impaired liver function
- Cholestasis
- Chronic alcohol or drug abuse
- Evidence of significantly impaired renal function (
- Diabetes mellitus (type I or II) with significant peripheral neuropathy and/or polyuria
- Inflammatory bowel disease such as Crohn's disease, or ulcerative colitis
- Uncontrolled narrow angle glaucoma
- Chronic use of carbamazepine or paracetamol
- Participation in any drug study in the preceding 3 months
- Concomitant treatment with strong CYP3A4 inhibitors
- History or evidence of relevant cardiovascular or cerebrovascular disorders
Trial locations and contacts
31 sites in 3 countries.
31 sites in 3 countries
Germany18 sites
Private Gynecological Practice
Alzey, 55232
Private Urologic Practice
Berlin, 12247
Private Urologic Practice
Berlin, 13057
Private Urologic Practice
Borken, 46325
Private Urologic Practice
Duisburg, 47051
Private Urologic Practice
Duisburg, 47179
Private Urologic Practice
Essen, 45355
Private Urologic Practice
Greifswald, 17493
Private Urologic Practice
Hamburg, 20097
Private Urologic Practice
Hamburg, 20249
Private Urologic Practice
Homburg Saar, 66424
Private Urologic Practice
Kleinblittersdorf, 66271
Private Urologic Practice
Marburg, 35037
Private Urologic Practice
Mühlacker, 75417
Private Urologic Practice
Mülheim, 45468
Private Urologic Practice
Munich, 81925
Private Urologic Practice
Oberursel, 61440
Private Urologic Practice
Stuttgart, 70372
Poland9 sites
NZOZ Centrum Medyczne dr n. med. Artur Racewicz
Bialystok, 15-337
Urovita Sp z o.o.
Chorzów, 41-500
Invicta Sp z o.o.
Gdansk, 80-850
Szpital Specjalistyczny w Koscierzynie, Dep. Oddzial Urologii
Kościerzyna, 83-400
NZOZ Specjalista Sp. z o.o.
Kutno, 99-300
NZOZ Nasz Lekarz, Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna
Torun, 87-100
Szpital Kliniczny - Centrum Leczenia Obrazen "Dzieciatka Jezus"
Warsaw, 02-005
Centrum Leczenia Chorob Cywilizacyjnych Andrzej Opadczuk
Warsaw, 02-777
EMC Instytut Medyczny S.A., EuroMediCare, Szpital Specjalistyczny z Przychodnia
Wroclaw, 54-144
Sweden4 sites
University Hospital Linköping
Linköping, 581 85
Karolinska University Hospital Huddinge
Stockholm, 141 86
Danderyds Hospital
Stockholm, 182 88
University Hospital Uppsala
Uppsala, 751 85
About this study
Official title: A Multicenter, Randomized, Double-Blind, Parallel Group, Phase II, Forced Dose Titration Study to Investigate the Efficacy and Safety of 400mg and 600mg ELB245 Given Once Daily for 12 Weeks (8 + 4 Weeks) Versus Placebo and Versus 4mg Tolterodine Given Once Daily in Patients With Incontinent Overactive Bladder (OAB)
This study is designed to determine the efficacy of escalating doses of ELB245 versus placebo , when administered to patients with OAB and to compare the efficacy of escalating doses of ELB245 versus the standard treatment tolterodine, when administered to patients with OAB.
- Conditions
- Overactive Bladder, Urinary Incontinence
- Being tested
- ELB245, Tolterodine
- Keywords
- OAB, proof of concept, Overactive Bladder (OAB), with incontinence
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELB245Drug
TolterodineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
mean number of micturitions
Secondary outcomes (3)
OAB related measures
urgency measures
Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2007 (estimated)
- Study startFeb 2007
- Study completionAug 2007
Why it stopped: side effect profile did not match expectations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies 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
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- elbion AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Martin Michel, Prof., Study chair, Dept. Pharmacology & Pharmacotherapy, AMC, University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439192
- Sponsor's protocol ID
- ELB245201-06
- Status last verified
- Aug 2007
- First submitted
- 22 Feb 2007
- Last updated
- 8 Aug 2007
- Results posted
- No
Publications
Song T, Hayanga J, Durham L, Garrison L, McCarthy P, Barksdale A, Smith D, Bartlett R, Jaros M, Nelson P, Molnar Z, Deliargyris E, Moazami N. CytoSorb Therapy in COVID-19 (CTC) Patients Requiring Extracorporeal Membrane Oxygenation: A Multicenter, Retrospective Registry. Front Med (Lausanne). 2021 Dec 20;8:773461. doi: 10.3389/fmed.2021.773461. eCollection 2021.
PubMed 34988092
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Parallel Group, Phase II, Forced Dose Titration Study to Investigate the Efficacy and Safety of 400mg and 600mg ELB245 Given Once Daily for 12 Weeks (8 + 4 Weeks) Versus Placebo and Versus 4mg Tolterodine Given Once Daily in Patients With Incontinent Overactive Bladder (OAB)
- ClinicalTrials.gov ID
- NCT00439192
- Acronym / sponsor ID
- ELB245201-06
- Conditions
- Overactive Bladder, Urinary Incontinence
- Keywords
- OAB, proof of concept, Overactive Bladder (OAB), with incontinence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: side effect profile did not match expectations
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- elbion AGIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Study completion
- Aug 2007 (actual)
- First posted
- 23 Feb 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.
This study is designed to determine the efficacy of escalating doses of ELB245 versus placebo , when administered to patients with OAB and to compare the efficacy of escalating doses of ELB245 versus the standard treatment tolterodine, when administered to patients with OAB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female outpatients at least 18 years of age
- Symptoms of OAB for a minimum of 3 consecutive months prior to study entry; severity of OAB (as defined by patient reported symptoms) for a minimum of one month prior to study entry
- Ability to use a toilet independently and without difficulty
- No treatment with any medication against OAB during the 4 weeks prior to study entry
- Written informed consent
Key exclusion criteria (20 listed)
- Breastfeeding women, pregnant women or women who intend to become pregnant during the study or women of childbearing potential who are sexually active and not practicing a highly reliable method of birth control
- Any local pathology, that might cause the bladder symptoms
- Significant stress urinary incontinence or mixed stress/urgency incontinence
- Any neurological disease affecting bladder function or muscle strength
- Patient history of any lower urinary tract surgery or previous pelvic irradiation
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 |
|---|---|---|
| ELB245 | Drug | – |
| Tolterodine | Drug | – |
Primary outcome
mean number of micturitions
3 secondary outcomes
OAB related measures
urgency measures
Quality of life
Results and safety
The study was stopped early (reason given: side effect profile did not match expectations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2007.
- Derived from this study: PubMed 34988092Song T, Hayanga J, Durham L, Garrison L, McCarthy P, Barksdale A, Smith D, Bartlett R, Jaros M, Nelson P, Molnar Z, Deliargyris E, Moazami N. CytoSorb Therapy in COVID-19 (CTC) Patients Requiring Extracorporeal Membrane Oxygenation: A Multicenter, Retrospective Registry. Front Med (Lausanne). 2021 Dec 20;8:773461. doi: 10.3389/fmed.2021.773461. eCollection 2021.
Related trials for Overactive Bladder
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
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.
Martin Michel, Prof. study chair
Dept. Pharmacology & Pharmacotherapy, AMC, University of Amsterdam
31 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ELB245 and Tolterodine in people with Overactive Bladder and Urinary Incontinence, run by elbion AG at 31 sites in 3 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 5 inclusion and 20 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 8 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Germany, Poland, Sweden. 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: side effect profile did not match expectations). 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?
mean number of micturitions. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00439192, which also lists 1 linked publication.
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 Aug 2007.