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

Phase 2

Terminated

• Conditions: Overactive Bladder; Urinary Incontinence

• Registration Number: NCT00439192
• Lead Sponsor: elbion AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-02-22
• Study First Submitted QC: 2007-02-22
• Study First Posted: 2007-02-23
• Status Verified: 2007-08
• Study Completion: 2007-08
• Last Update Submitted: 2007-08-07
• Last Update Posted: 2007-08-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 275

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
mean number of micturitions

Secondary Outcome Measures

Name	Time	Method
OAB related measures
urgency measures
Quality of life

Trial Locations

Locations (15)

Danderyds Hospital; 🇸🇪 Stockholm, Sweden

University Hospital Uppsala; 🇸🇪 Uppsala, Sweden

Karolinska University Hospital Huddinge; 🇸🇪 Stockholm, Sweden

Private Gynecological Practice; 🇩🇪 Alzey, Germany

Private Urologic Practice; 🇩🇪 Stuttgart, Germany

Invicta Sp z o.o.; 🇵🇱 Gdansk, Poland

NZOZ Specjalista Sp. z o.o.; 🇵🇱 Kutno, Poland

University Hospital Linköping; 🇸🇪 Linköping, Sweden

Szpital Specjalistyczny w Koscierzynie, Dep. Oddzial Urologii; 🇵🇱 Koscierzyna, Poland

NZOZ Centrum Medyczne dr n. med. Artur Racewicz; 🇵🇱 Bialystok, Poland

Urovita Sp z o.o.; 🇵🇱 Chorzow, Poland

NZOZ Nasz Lekarz, Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna; 🇵🇱 Torun, Poland

Szpital Kliniczny - Centrum Leczenia Obrazen "Dzieciatka Jezus"; 🇵🇱 Warszawa, Poland

Centrum Leczenia Chorob Cywilizacyjnych Andrzej Opadczuk; 🇵🇱 Warszawa, Poland

EMC Instytut Medyczny S.A., EuroMediCare, Szpital Specjalistyczny z Przychodnia; 🇵🇱 Wroclaw, Poland