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
  Purpose

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 Intervention Phase
Overactive Bladder
Urinary Incontinence
Drug: ELB245
Drug: Tolterodine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:


Further study details as provided by elbion AG:

Primary Outcome Measures:
  • mean number of micturitions

Secondary Outcome Measures:
  • OAB related measures
  • urgency measures
  • Quality of life

Estimated Enrollment: 275
Study Start Date: February 2007
Study Completion Date: August 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00439192

Locations
Germany
Private Gynecological Practice
Alzey, Germany, 55232
Private Urologic Practice
Berlin, Germany, 13057
Private Urologic Practice
Berlin, Germany, 12247
Private Urologic Practice
Borken, Germany, 46325
Private Urologic Practice
Duisburg, Germany, 47179
Private Urologic Practice
Duisburg, Germany, 47051
Private Urologic Practice
Essen, Germany, 45355
Private Urologic Practice
Greifswald, Germany, 17493
Private Urologic Practice
Hamburg, Germany, 20249
Private Urologic Practice
Hamburg, Germany, 20097
Private Urologic Practice
Homburg Saar, Germany, 66424
Private Urologic Practice
Kleinblittersdorf, Germany, 66271
Private Urologic Practice
Marburg, Germany, 35037
Private Urologic Practice
Muelheim, Germany, 45468
Private Urologic Practice
Munich, Germany, 81925
Private Urologic Practice
Mühlacker, Germany, 75417
Private Urologic Practice
Oberursel, Germany, 61440
Private Urologic Practice
Stuttgart, Germany, 70372
Poland
NZOZ Centrum Medyczne dr n. med. Artur Racewicz
Bialystok, Poland, 15-337
Urovita Sp z o.o.
Chorzow, Poland, 41-500
Invicta Sp z o.o.
Gdansk, Poland, 80-850
Szpital Specjalistyczny w Koscierzynie, Dep. Oddzial Urologii
Koscierzyna, Poland, 83-400
NZOZ Specjalista Sp. z o.o.
Kutno, Poland, 99-300
NZOZ Nasz Lekarz, Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna
Torun, Poland, 87-100
Szpital Kliniczny - Centrum Leczenia Obrazen "Dzieciatka Jezus"
Warszawa, Poland, 02-005
Centrum Leczenia Chorob Cywilizacyjnych Andrzej Opadczuk
Warszawa, Poland, 02-777
EMC Instytut Medyczny S.A., EuroMediCare, Szpital Specjalistyczny z Przychodnia
Wroclaw, Poland, 54-144
Sweden
University Hospital Linköping
Linköping, Sweden, 581 85
Karolinska University Hospital Huddinge
Stockholm, Sweden, 141 86
Danderyds Hospital
Stockholm, Sweden, 182 88
University Hospital Uppsala
Uppsala, Sweden, 751 85
Sponsors and Collaborators
elbion AG
Investigators
Study Chair: Martin Michel, Prof. Dept. Pharmacology & Pharmacotherapy, AMC, University of Amsterdam
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00439192     History of Changes
Other Study ID Numbers: ELB245201-06
Study First Received: February 22, 2007
Last Updated: August 7, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Sweden: Medical Products Agency
Poland: Ministry of Health

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
Urinary Bladder Diseases
Tolterodine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014