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

August 7, 2007 updated by: elbion AG

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

275

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Alzey, Germany, 55232
        • Private Gynecological Practice
      • Berlin, Germany, 12247
        • Private Urologic Practice
      • Berlin, Germany, 13057
        • Private Urologic Practice
      • Borken, Germany, 46325
        • Private Urologic Practice
      • Duisburg, Germany, 47051
        • Private Urologic Practice
      • Duisburg, Germany, 47179
        • Private Urologic Practice
      • Essen, Germany, 45355
        • Private Urologic Practice
      • Greifswald, Germany, 17493
        • Private Urologic Practice
      • Hamburg, Germany, 20097
        • Private Urologic Practice
      • Hamburg, Germany, 20249
        • 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
        • Private Urologic Practice
  • Poland
      • Bialystok, Poland, 15-337
        • NZOZ Centrum Medyczne dr n. med. Artur Racewicz
      • Chorzow, Poland, 41-500
        • Urovita Sp z o.o.
      • Gdansk, Poland, 80-850
        • Invicta Sp z o.o.
      • Koscierzyna, Poland, 83-400
        • Szpital Specjalistyczny w Koscierzynie, Dep. Oddzial Urologii
      • Kutno, Poland, 99-300
        • NZOZ Specjalista Sp. z o.o.
      • Torun, Poland, 87-100
        • NZOZ Nasz Lekarz, Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna
      • Warszawa, Poland, 02-005
        • Szpital Kliniczny - Centrum Leczenia Obrazen "Dzieciatka Jezus"
      • Warszawa, Poland, 02-777
        • Centrum Leczenia Chorob Cywilizacyjnych Andrzej Opadczuk
      • Wroclaw, Poland, 54-144
        • EMC Instytut Medyczny S.A., EuroMediCare, Szpital Specjalistyczny z Przychodnia
  • Sweden
      • Linköping, Sweden, 581 85
        • University Hospital Linköping
      • Stockholm, Sweden, 182 88
        • Danderyds Hospital
      • Stockholm, Sweden, 141 86
        • Karolinska University Hospital Huddinge
      • Uppsala, Sweden, 751 85
        • University hospital Uppsala

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
mean number of micturitions

Secondary Outcome Measures

Outcome Measure
Quality of life
OAB related measures
urgency measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

elbion AG

Investigators

  • Study Chair: Martin Michel, Prof., Dept. Pharmacology & Pharmacotherapy, AMC, University of Amsterdam

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

February 22, 2007

First Submitted That Met QC Criteria

February 22, 2007

First Posted (Estimate)

February 23, 2007

Study Record Updates

Last Update Posted (Estimate)

August 8, 2007

Last Update Submitted That Met QC Criteria

August 7, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELB245201-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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