ELB245 for 12 Weeks Versus 4mg Tolterodine in Patients With Incontinent Overactive Bladder (OAB)

NCT ID: NCT00439192

Last Updated: 2007-08-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 275 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2007-08-31

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.

Conditions

Overactive Bladder; Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

ELB245

Intervention Type: DRUG

Tolterodine

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

elbion AG

INDUSTRY

Sponsor Role: lead

Principal Investigators

Martin Michel, Prof.

Role: STUDY_CHAIR

Dept. Pharmacology & Pharmacotherapy, AMC, University of Amsterdam

Locations

Private Gynecological Practice

Alzey, , Germany

Private Urologic Practice

Berlin, , Germany

Private Urologic Practice

Berlin, , Germany

Private Urologic Practice

Borken, , Germany

Private Urologic Practice

Duisburg, , Germany

Private Urologic Practice

Duisburg, , Germany

Private Urologic Practice

Essen, , Germany

Private Urologic Practice

Greifswald, , Germany

Private Urologic Practice

Hamburg, , Germany

Private Urologic Practice

Hamburg, , Germany

Private Urologic Practice

Homburg Saar, , Germany

Private Urologic Practice

Kleinblittersdorf, , Germany

Private Urologic Practice

Marburg, , Germany

Private Urologic Practice

Munich, , Germany

Private Urologic Practice

Mühlacker, , Germany

Private Urologic Practice

Mülheim, , Germany

Private Urologic Practice

Oberursel, , Germany

Private Urologic Practice

Stuttgart, , Germany

NZOZ Centrum Medyczne dr n. med. Artur Racewicz

Bialystok, , Poland

Urovita Sp z o.o.

Chorzów, , Poland

Invicta Sp z o.o.

Gdansk, , Poland

Szpital Specjalistyczny w Koscierzynie, Dep. Oddzial Urologii

Kościerzyna, , Poland

NZOZ Specjalista Sp. z o.o.

Kutno, , Poland

NZOZ Nasz Lekarz, Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna

Torun, , Poland

Szpital Kliniczny - Centrum Leczenia Obrazen "Dzieciatka Jezus"

Warsaw, , Poland

Centrum Leczenia Chorob Cywilizacyjnych Andrzej Opadczuk

Warsaw, , Poland

EMC Instytut Medyczny S.A., EuroMediCare, Szpital Specjalistyczny z Przychodnia

Wroclaw, , Poland

University Hospital Linköping

Linköping, , Sweden

Karolinska University Hospital Huddinge

Stockholm, , Sweden

Danderyds Hospital

Stockholm, , Sweden

University Hospital Uppsala

Uppsala, , Sweden

Countries

Germany; Poland; Sweden

References

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.

Reference Type: DERIVED

PMID: 34988092 (View on PubMed)

Other Identifiers

ELB245201-06

Identifier Type: -

Identifier Source: org_study_id