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

elbion

Status and phase

Terminated

Phase 2

Conditions

Urinary Incontinence

Overactive Bladder

Treatments

Drug: Tolterodine

Drug: ELB245

Study type

Interventional

Funder types

Industry

Identifiers

NCT00439192

ELB245201-06

Details and patient eligibility

About

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.

Enrollment

275 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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