Overactive Bladder, Urinary Incontinence
Conditions
Keywords
OAB, proof of concept, Overactive Bladder (OAB), with incontinence
Brief 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.
Interventions
DRUGELB245
DRUGTolterodine
Sponsors
elbion AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mean number of micturitions | — |
Secondary
| Measure | Time frame |
|---|---|
| OAB related measures | — |
| urgency measures | — |
| Quality of life | — |
Countries
Germany, Poland, Sweden
Outcome results
None listed