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

• Status: Terminated
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: elbion AG
• Treatments: Tolterodine Tartrate

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