Clinical trial NCT00439192: ELB245 for 12 Weeks Versus 4mg Tolterodine in Patients With Incontinent Overactive Bladder (OAB)
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Overactive Bladder
Urinary Incontinence
Keywords: OAB, proof of concept
Overactive Bladder (OAB)
with incontinence
Lead sponsor: elbion AG
Sponsor class: INDUSTRY
First posted: 2007-02-23
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: mean number of micturitions
Secondary outcomes:
measure: OAB related measures
measure: urgency measures
measure: Quality of life
Other outcomes:
Locations:
city: Alzey
country: Germany
facility: Private Gynecological Practice
city: Berlin
country: Germany
facility: Private Urologic Practice
city: Berlin
country: Germany
facility: Private Urologic Practice
city: Borken
country: Germany
facility: Private Urologic Practice
city: Duisburg
country: Germany
facility: Private Urologic Practice
city: Duisburg
country: Germany
facility: Private Urologic Practice
city: Essen
country: Germany
facility: Private Urologic Practice
city: Greifswald
country: Germany
facility: Private Urologic Practice
city: Hamburg
country: Germany
facility: Private Urologic Practice
city: Hamburg
country: Germany
facility: Private Urologic Practice
city: Homburg Saar
country: Germany
facility: Private Urologic Practice
city: Kleinblittersdorf
country: Germany
facility: Private Urologic Practice
city: Marburg
country: Germany
facility: Private Urologic Practice
city: Muelheim
country: Germany
facility: Private Urologic Practice
city: Munich
country: Germany
facility: Private Urologic Practice
city: Mühlacker
country: Germany
facility: Private Urologic Practice
city: Oberursel
country: Germany
facility: Private Urologic Practice
city: Stuttgart
country: Germany
facility: Private Urologic Practice
city: Bialystok
country: Poland
facility: NZOZ Centrum Medyczne dr n. med. Artur Racewicz
city: Chorzow
country: Poland
facility: Urovita Sp z o.o.
city: Gdansk
country: Poland
facility: Invicta Sp z o.o.
city: Koscierzyna
country: Poland
facility: Szpital Specjalistyczny w Koscierzynie, Dep. Oddzial Urologii
city: Kutno
country: Poland
facility: NZOZ Specjalista Sp. z o.o.
city: Torun
country: Poland
facility: NZOZ Nasz Lekarz, Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna
city: Warszawa
country: Poland
facility: Szpital Kliniczny - Centrum Leczenia Obrazen "Dzieciatka Jezus"
city: Warszawa
country: Poland
facility: Centrum Leczenia Chorob Cywilizacyjnych Andrzej Opadczuk
city: Wroclaw
country: Poland
facility: EMC Instytut Medyczny S.A., EuroMediCare, Szpital Specjalistyczny z Przychodnia
city: Linköping
country: Sweden
facility: University Hospital Linköping
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Huddinge
city: Stockholm
country: Sweden
facility: Danderyds Hospital
city: Uppsala
country: Sweden
facility: University Hospital Uppsala
Study officials:
affiliation: Dept. Pharmacology & Pharmacotherapy, AMC, University of Amsterdam
name: Martin Michel, Prof.
role: STUDY_CHAIR
References:
citation: 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.