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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00439192
Recruitment Status : Terminated (side effect profile did not match expectations)
First Posted : February 23, 2007
Last Update Posted : August 8, 2007
Information provided by:
elbion AG

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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Urinary Incontinence Drug: ELB245 Drug: Tolterodine Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 275 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : February 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. mean number of micturitions

Secondary Outcome Measures :
  1. OAB related measures
  2. urgency measures
  3. Quality of life

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00439192

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Sponsors and Collaborators
elbion AG
Study Chair: Martin Michel, Prof. Dept. Pharmacology & Pharmacotherapy, AMC, University of Amsterdam Identifier: NCT00439192     History of Changes
Other Study ID Numbers: ELB245201-06
First Posted: February 23, 2007    Key Record Dates
Last Update Posted: August 8, 2007
Last Verified: August 2007

Keywords provided by elbion AG:
OAB, proof of concept
Overactive Bladder (OAB)
with incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Urinary Bladder Diseases
Tolterodine Tartrate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents