Status:
TERMINATED
ELB245 for 12 Weeks Versus 4mg Tolterodine in Patients With Incontinent Overactive Bladder (OAB)
Lead Sponsor:
elbion AG
Conditions:
Overactive Bladder
Urinary Incontinence
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2007
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT00439192
Start Date
February 1 2007
End Date
August 1 2007
Last Update
August 8 2007
Active Locations (31)
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1
Private Gynecological Practice
Alzey, Germany, 55232
2
Private Urologic Practice
Berlin, Germany, 12247
3
Private Urologic Practice
Berlin, Germany, 13057
4
Private Urologic Practice
Borken, Germany, 46325