Neurogenic overactive bladder disaese in patients with multiple sclerosis MedDRA version: 8.1 Level: LLT Classification code 10059617 Term: Overactive bladder
Conditions
Interventions
Trade Name: EMSELEX 7,5 mg Retardtabletten
Product Name: Darifenacin
Product Code: BAY 79-4998
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Darifenacin
Current Sponsor code: Bay
Sponsors
Bayer Vital GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At Screening • Male and female patients aged 18 years with the diagnosis of multiple sclerosis • Neurogenic detrusor overactivity without DSD as confirmed by the baseline urodynamics during this study. • Symptoms of OAB as defined by - micturitions/day 8 and more, respectively - urgency episodes per day 1 and more, respectively • Patients capable of understanding the given information and having signed Patient Informed Consent Form after full discussion of the research nature of the treatment and its risks and benefits • Patients capable of independently completing the bladder diary • Patients capable of independent toileting • Patients able to swallow the study medication in accordance to the protocol • Body Mass Index equal to or greater than 18.5 kg/m2 and less than 35.0 kg/m2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: At Screening • Treatment with drugs known to affect mainly the urinary bladder function • Participation in a bladder-training program or any electro stimulation therapy within the 2 weeks prior to Visit 1 • Low compliance bladder (Compliance 200 mL at Baseline • Urinary retention or clinically significant bladder outlet obstruction • Low pressure reflux • Clinically predominant and bothersome stress urinary incontinence • Neurological diseases other than multiple sclerosis affecting • Any clinically significant congenital or acquired disorder of the urogenital tract • Any urogenital surgery within 12 months prior to Visit 1 • Any history of pelvic radiation therapy • Females with urinary symptoms secondary to cystocele or pelvic organ prolapse greater than stage 2 • Chronic persistent local pathology that in the opinion of the investigator may lead to urinary symptoms, such as one of the genito-urinary pain syndromes, interstitial cystitis; fecal impaction and severe constipation • Three or more urinary tract infections per year over the preceding 12 months • Unexplained haematuria • Any history of carcinoma of the urogenital tract. • Concomitant diseases in which the use of darifenacin is contraindicated • Significant medical problems, including but not limited to the following: uncontrolled severe hypertension, uncontrolled severe heart failure, myocardial infarction in the last 6 months, uncontrolled thyroid disease (unless the patient is on controlled thyroid hormone for at least 3 months), or evidence (from direct questioning and/or physical examination) of any clinically significant systemic disease that in the investigator’s opinion makes the patient unfit to participate in the study • Evidence, based on laboratory tests done at Visit 1, of: Hepatic disorder (ALT or AST > 1.5 x upper normal limit [ULN]; bilirubin > 1.2 x ULN unless secondary to Gilbert’s disease in the opinion of the investigator) Blood coagulation disorder (e.g. haemophilia) Anemia (haemoglobin > 2 g/dL [20 g/L] below the lower limit of normal) • Currently receiving or have received the following medications within two weeks prior to Visit 2 and at any time during the study: - Cholinergic agonists and cholinesterase inhibitors e.g. bethanecol, donepezil, rivastigmine - Potent inhibitors of cytochrome CYP3A4 and potent P-glycoprotein inhibitors such as cyclosporine and verapamil. • Treatment with an unstable dose of any drug having the potential for significant anticholinergic side effects in the last 4 weeks prior to Visit 1 • Women of child-bearing potential defined as all women physiologically capable of becoming pregnant, unless they are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g. bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: hormonal IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). Acceptable methods of contraception may also include total abstinence at the discretion of the investigator. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post- ovulation methods) and withdrawal are not acceptable methods of contracep
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate accidental evidence (casuistic findings) in more detail and to show efficacy of darifenacin in the treatment of multiple sclerosis patients with neurogenic overactive bladder ;Secondary Objective: none;Primary end point(s): • volume at first detrusor contraction | — |
Countries
Germany
Outcome results
None listed