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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: ELB245
• Drug: Tolterodine

Primary Measures

• mean number of micturitions

Secondary Measures

• OAB related measures
• urgency measures
• Quality of life

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: elbion AG

Overall Clinical Trial Officials and Contacts

Martin Michel, Prof. Study Chair Dept. Pharmacology & Pharmacotherapy, AMC, University of Amsterdam  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00439192

Study ID Number: ELB245201-06

ClinicalTrials.gov Identifier: NCT00439192

Health Authority: Germany: Federal Institute for Drugs and Medical Devices