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

This study has been terminated.
(side effect profile did not match expectations)
Sponsor:
Information provided by:
elbion AG
ClinicalTrials.gov Identifier:
NCT00439192
First received: February 22, 2007
Last updated: August 7, 2007
Last verified: August 2007

February 22, 2007
August 7, 2007
February 2007
Not Provided
mean number of micturitions
Same as current
Complete list of historical versions of study NCT00439192 on ClinicalTrials.gov Archive Site
  • OAB related measures
  • urgency measures
  • Quality of life
Same as current
Not Provided
Not Provided
 
ELB245 for 12 Weeks Versus 4mg Tolterodine in Patients With Incontinent Overactive Bladder (OAB)
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)

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Overactive Bladder
  • Urinary Incontinence
  • Drug: ELB245
  • Drug: Tolterodine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
275
August 2007
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Poland,   Sweden
 
NCT00439192
ELB245201-06
Not Provided
Not Provided
elbion AG
Not Provided
Study Chair: Martin Michel, Prof. Dept. Pharmacology & Pharmacotherapy, AMC, University of Amsterdam
elbion AG
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP