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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Overactive Bladder, Urinary Incontinence

Intervention / Treatment
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* Drug: ELB245
* Drug: Tolterodine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ELB245|nan|
|Drug: Tolterodine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean number of micturitions |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OAB related measures |  |  | 
| urgency measures |  |  | 
| Quality of life |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OAB, proof of concept, Overactive Bladder (OAB), with incontinence