Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:58 PM
Ignite Modification Date:
2025-12-24 @ 3:58 PM
NCT ID:
NCT00439192
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00439192
Study Brief:
Protocol Section:
NCT00439192