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

Urinary Incontinence Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00439192
• Other study ID #: ELB245201-06
• Status: Terminated
• Phase: Phase 2
• First received: February 22, 2007
• Last updated: August 7, 2007
• Start date: February 2007
• Est. completion date: August 2007

Study information

• Verified date: August 2007
• Source: elbion AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesSweden: Medical Products AgencyPoland: Ministry of Health
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 275
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive
• Urinary Incontinence

Intervention

Drug:
• ELB245

• Tolterodine

Locations

Country	Name	City	State
Germany	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	Muelheim
Germany	Private Urologic Practice	Mühlacker
Germany	Private Urologic Practice	Munich
Germany	Private Urologic Practice	Oberursel
Germany	Private Urologic Practice	Stuttgart
Poland	NZOZ Centrum Medyczne dr n. med. Artur Racewicz	Bialystok
Poland	Urovita Sp z o.o.	Chorzow
Poland	Invicta Sp z o.o.	Gdansk
Poland	Szpital Specjalistyczny w Koscierzynie, Dep. Oddzial Urologii	Koscierzyna
Poland	NZOZ Specjalista Sp. z o.o.	Kutno
Poland	NZOZ Nasz Lekarz, Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna	Torun
Poland	Centrum Leczenia Chorob Cywilizacyjnych Andrzej Opadczuk	Warszawa
Poland	Szpital Kliniczny - Centrum Leczenia Obrazen "Dzieciatka Jezus"	Warszawa
Poland	EMC Instytut Medyczny S.A., EuroMediCare, Szpital Specjalistyczny z Przychodnia	Wroclaw
Sweden	University Hospital Linköping	Linköping
Sweden	Danderyds Hospital	Stockholm
Sweden	Karolinska University Hospital Huddinge	Stockholm
Sweden	University Hospital Uppsala	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
elbion AG

Countries where clinical trial is conducted

Germany,  Poland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean number of micturitions
Secondary	OAB related measures
Secondary	urgency measures
Secondary	Quality of life