side effect profile did not match expectations

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.

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