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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 22, 2007

Last Updated Date

August 7, 2007

Start Date ^ICMJE

February 2007

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

mean number of micturitions

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00439192 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

OAB related measures
urgency measures
Quality of life

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Overactive Bladder
Urinary Incontinence

Intervention ^ICMJE

Drug: ELB245
Drug: Tolterodine

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

275

Completion Date

August 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany, Poland, Sweden

Administrative Information

NCT Number ^ICMJE

NCT00439192

Other Study ID Numbers ^ICMJE

ELB245201-06

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

elbion AG

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Martin Michel, Prof.

Dept. Pharmacology & Pharmacotherapy, AMC, University of Amsterdam

Information Provided By

elbion AG

Verification Date

August 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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