Back to resultsELB245 for 12 Weeks Versus 4mg Tolterodine in Patients With Incontinent Overactive Bladder (OAB)
Primary Purpose
Overactive Bladder, Urinary Incontinence
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ELB245
Tolterodine
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder focused on measuring OAB, proof of concept, Overactive Bladder (OAB), with incontinence
Eligibility 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
Sites / Locations
- Private Gynecological Practice
- Private Urologic Practice
- Private Urologic Practice
- Private Urologic Practice
- Private Urologic Practice
- Private Urologic Practice
- Private Urologic Practice
- Private Urologic Practice
- Private Urologic Practice
- Private Urologic Practice
- Private Urologic Practice
- Private Urologic Practice
- Private Urologic Practice
- Private Urologic Practice
- Private Urologic Practice
- Private Urologic Practice
- Private Urologic Practice
- Private Urologic Practice
- NZOZ Centrum Medyczne dr n. med. Artur Racewicz
- Urovita Sp z o.o.
- Invicta Sp z o.o.
- Szpital Specjalistyczny w Koscierzynie, Dep. Oddzial Urologii
- NZOZ Specjalista Sp. z o.o.
- NZOZ Nasz Lekarz, Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna
- Szpital Kliniczny - Centrum Leczenia Obrazen "Dzieciatka Jezus"
- Centrum Leczenia Chorob Cywilizacyjnych Andrzej Opadczuk
- EMC Instytut Medyczny S.A., EuroMediCare, Szpital Specjalistyczny z Przychodnia
- University Hospital Linköping
- Karolinska University Hospital Huddinge
- Danderyds Hospital
- University Hospital Uppsala
Outcomes
Primary Outcome Measures
mean number of micturitions
Secondary Outcome Measures
OAB related measures
urgency measures
Quality of life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00439192
Brief Title
ELB245 for 12 Weeks Versus 4mg Tolterodine in Patients With Incontinent Overactive Bladder (OAB)
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 Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Terminated
Why Stopped
side effect profile did not match expectations
Study Start Date
February 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
elbion AG
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Urinary Incontinence
Keywords
OAB, proof of concept, Overactive Bladder (OAB), with incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
275 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ELB245
Intervention Type
Drug
Intervention Name(s)
Tolterodine
Primary Outcome Measure Information:
Title
mean number of micturitions
Secondary Outcome Measure Information:
Title
OAB related measures
Title
urgency measures
Title
Quality of life
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Michel, Prof.
Organizational Affiliation
Dept. Pharmacology & Pharmacotherapy, AMC, University of Amsterdam
Official's Role
Study Chair
Facility Information:
Facility Name
Private Gynecological Practice
City
Alzey
ZIP/Postal Code
55232
Country
Germany
Facility Name
Private Urologic Practice
City
Berlin
ZIP/Postal Code
12247
Country
Germany
Facility Name
Private Urologic Practice
City
Berlin
ZIP/Postal Code
13057
Country
Germany
Facility Name
Private Urologic Practice
City
Borken
ZIP/Postal Code
46325
Country
Germany
Facility Name
Private Urologic Practice
City
Duisburg
ZIP/Postal Code
47051
Country
Germany
Facility Name
Private Urologic Practice
City
Duisburg
ZIP/Postal Code
47179
Country
Germany
Facility Name
Private Urologic Practice
City
Essen
ZIP/Postal Code
45355
Country
Germany
Facility Name
Private Urologic Practice
City
Greifswald
ZIP/Postal Code
17493
Country
Germany
Facility Name
Private Urologic Practice
City
Hamburg
ZIP/Postal Code
20097
Country
Germany
Facility Name
Private Urologic Practice
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Facility Name
Private Urologic Practice
City
Homburg Saar
ZIP/Postal Code
66424
Country
Germany
Facility Name
Private Urologic Practice
City
Kleinblittersdorf
ZIP/Postal Code
66271
Country
Germany
Facility Name
Private Urologic Practice
City
Marburg
ZIP/Postal Code
35037
Country
Germany
Facility Name
Private Urologic Practice
City
Muelheim
ZIP/Postal Code
45468
Country
Germany
Facility Name
Private Urologic Practice
City
Munich
ZIP/Postal Code
81925
Country
Germany
Facility Name
Private Urologic Practice
City
Mühlacker
ZIP/Postal Code
75417
Country
Germany
Facility Name
Private Urologic Practice
City
Oberursel
ZIP/Postal Code
61440
Country
Germany
Facility Name
Private Urologic Practice
City
Stuttgart
ZIP/Postal Code
70372
Country
Germany
Facility Name
NZOZ Centrum Medyczne dr n. med. Artur Racewicz
City
Bialystok
ZIP/Postal Code
15-337
Country
Poland
Facility Name
Urovita Sp z o.o.
City
Chorzow
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Invicta Sp z o.o.
City
Gdansk
ZIP/Postal Code
80-850
Country
Poland
Facility Name
Szpital Specjalistyczny w Koscierzynie, Dep. Oddzial Urologii
City
Koscierzyna
ZIP/Postal Code
83-400
Country
Poland
Facility Name
NZOZ Specjalista Sp. z o.o.
City
Kutno
ZIP/Postal Code
99-300
Country
Poland
Facility Name
NZOZ Nasz Lekarz, Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Szpital Kliniczny - Centrum Leczenia Obrazen "Dzieciatka Jezus"
City
Warszawa
ZIP/Postal Code
02-005
Country
Poland
Facility Name
Centrum Leczenia Chorob Cywilizacyjnych Andrzej Opadczuk
City
Warszawa
ZIP/Postal Code
02-777
Country
Poland
Facility Name
EMC Instytut Medyczny S.A., EuroMediCare, Szpital Specjalistyczny z Przychodnia
City
Wroclaw
ZIP/Postal Code
54-144
Country
Poland
Facility Name
University Hospital Linköping
City
Linköping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Karolinska University Hospital Huddinge
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Danderyds Hospital
City
Stockholm
ZIP/Postal Code
182 88
Country
Sweden
Facility Name
University Hospital Uppsala
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
34988092
Citation
Song T, Hayanga J, Durham L, Garrison L, McCarthy P, Barksdale A, Smith D, Bartlett R, Jaros M, Nelson P, Molnar Z, Deliargyris E, Moazami N. CytoSorb Therapy in COVID-19 (CTC) Patients Requiring Extracorporeal Membrane Oxygenation: A Multicenter, Retrospective Registry. Front Med (Lausanne). 2021 Dec 20;8:773461. doi: 10.3389/fmed.2021.773461. eCollection 2021.
Results Reference
derived
Learn more about this trial
ELB245 for 12 Weeks Versus 4mg Tolterodine in Patients With Incontinent Overactive Bladder (OAB)
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