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

NCT00439192 | Terminated Phase 2

• 1 other identifier: ELB245201-06
• Study Type: interventional
• Target: 275
• Locations: 3 countries
• Sites: 31

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.

Conditions

Overactive Bladder; Urinary Incontinence

Keywords

OAB, proof of concept; Overactive Bladder (OAB); with incontinence

Outcome Measures

Primary Outcomes (1)

• mean number of micturitions

Secondary Outcomes (3)

• OAB related measures

• urgency measures

• Quality of life

Interventions

ELB245 DRUG

Tolterodine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• elbion AG: lead

Study Sites (31)

Private Gynecological Practice

Alzey, 55232, Germany

Location

Private Urologic Practice

Berlin, 12247, Germany

Location

Private Urologic Practice

Berlin, 13057, Germany

Location

Private Urologic Practice

Borken, 46325, Germany

Location

Private Urologic Practice

Duisburg, 47051, Germany

Location

Private Urologic Practice

Duisburg, 47179, Germany

Location

Private Urologic Practice

Essen, 45355, Germany

Location

Private Urologic Practice

Greifswald, 17493, Germany

Location

Private Urologic Practice

Hamburg, 20097, Germany

Location

Private Urologic Practice

Hamburg, 20249, Germany

Location

Private Urologic Practice

Homburg Saar, 66424, Germany

Location

Private Urologic Practice

Kleinblittersdorf, 66271, Germany

Location

Private Urologic Practice

Marburg, 35037, Germany

Location

Private Urologic Practice

Munich, 81925, Germany

Location

Private Urologic Practice

Mühlacker, 75417, Germany

Location

Private Urologic Practice

Mülheim, 45468, Germany

Location

Private Urologic Practice

Oberursel, 61440, Germany

Location

Private Urologic Practice

Stuttgart, 70372, Germany

Location

NZOZ Centrum Medyczne dr n. med. Artur Racewicz

Bialystok, 15-337, Poland

Location

Urovita Sp z o.o.

Chorzów, 41-500, Poland

Location

Invicta Sp z o.o.

Gdansk, 80-850, Poland

Location

Szpital Specjalistyczny w Koscierzynie, Dep. Oddzial Urologii

Kościerzyna, 83-400, Poland

Location

NZOZ Specjalista Sp. z o.o.

Kutno, 99-300, Poland

Location

NZOZ Nasz Lekarz, Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna

Torun, 87-100, Poland

Location

Szpital Kliniczny - Centrum Leczenia Obrazen "Dzieciatka Jezus"

Warsaw, 02-005, Poland

Location

Centrum Leczenia Chorob Cywilizacyjnych Andrzej Opadczuk

Warsaw, 02-777, Poland

Location

EMC Instytut Medyczny S.A., EuroMediCare, Szpital Specjalistyczny z Przychodnia

Wroclaw, 54-144, Poland

Location

University Hospital Linköping

Linköping, 581 85, Sweden

Location

Karolinska University Hospital Huddinge

Stockholm, 141 86, Sweden

Location

Danderyds Hospital

Stockholm, 182 88, Sweden

Location

University Hospital Uppsala

Uppsala, 751 85, Sweden

Location

Related Publications (1)

• 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.

  PMID: 34988092 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence

Interventions

Tolterodine Tartrate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Study Officials

• Martin Michel, Prof.

  Dept. Pharmacology & Pharmacotherapy, AMC, University of Amsterdam

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 22, 2007
• First Posted: February 23, 2007
• Study Start: February 1, 2007
• Study Completion: August 1, 2007
• Last Updated: August 8, 2007

Record last verified: 2007-08

Locations

PL (9); DE (18); SE (4)