Incontinent Overactive Bladder MedDRA version: 8.1 Level: LLT Classification code 10059617 Term: Overactive bladder
Conditions
Interventions
Trade Name: Trancolong® einmal täglich
Product Name: Flupirtine maleate
Product Code: ELB245
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Flupirtine maleate
CAS Number: 75507-68-5
Current S
Sponsors
elbion AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria to enter 2-week placebo run-in phase: 1. Male or female outpatients = 18 years of age 2. Symptoms of OAB for a minimum of 3 consecutive months prior to study entry; severity of OAB (as defined by patient reported symptoms of frequency = 8 micturition per 24 hours, urgency = 3 episodes per 24 hours, and urinary urgency incontinence on average = 1 per day), for a minimum of one month prior to study entry 3. Willing to comply with requirements of the study protocol including the completion of diaries and questionnaires 4. Ability to use a toilet independently and without difficulty 5. No treatment with any medication against OAB during the 4 weeks prior to study entry 6. Written informed consent Inclusion criteria at randomization 1. Symptoms of OAB based on patient diary entries during the placebo run in phase with • = 8 micturitions per 24 hours (based on a 3-day average) • = 3 episodes of urgency (strong desire to void) per 24 hours (based on a 3-day average) • = 1 episode of incontinence per 24 hours (based on a 3-day average) 2. No treatment with any medication against OAB during the placebo run in phase 3. Inclusion criteria 3 to 6 above have to be fulfilled 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: Exclusion criteria for 2-week placebo run-in phase: 1. 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 (these are methods with a failure quotient of one third of daily volume voided overnight) 10. History of liver disease and/or impaired liver function (alanine aminotransferase > 2 x upper limit of normal range (ULN), gamma glutamyl transferase > 2 x ULN, cholinesterase 2 x ULN, bilirubin > 2 x ULN) 13. Chronic alcohol or drug abuse 14. Evidence of significantly impaired renal function (serum creatinine > 2 x ULN, blood urea nitrogen [BUN] > 2 x ULN) 15. Diabetes mellitus (type I or II) with significant peripheral neuropathy and/or polyuria 16. Inflammatory bowel disease such as Crohn’s disease, or ulcerative colitis 17. Uncontrolled narrow angle glaucoma 18. Any significant disease or condition other than OAB which may put the patient at risk because of participation in the study or which may influence the results of the study or the patient’s ability to participate in the study 19. Chronic use of carbamazepine or paracetamol (on more than 5 consecutive days or on more than 5 days per month) 20. Participation in any drug study in the preceding 3 months 21. Established hypersensitivity to flupirtine, tolterodine or the excipients of the study medication 22. Concomitant treatment with strong CYP3A4 inhibitors (such as macrolid antibiotics [e.g. erythromycin] or antifungal agents [e.g. ketoconazol, and itraconazole] and antiproteases), diuretics (except patients on a stable dose for longer than 6 months) and anticho
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of escalating doses of flupirtine versus placebo based on mean number of micturitions per 24 hours (averaged over 3 consecutive days), when administered to patients with OAB. To determine the safety and tolerability of escalating doses of flupirtine versus placebo when administered to patients with OAB;Secondary Objective: To compare the efficacy of escalating doses of flupirtine versus the standard treatment tolterodine based on mean number of micturitions per 24 hours (averaged over 3 consecutive days), when administered to patients with OAB To compare safety and tolerability versus tolterodine when administered to patients with OAB;Primary end point(s): The change from baseline in the mean number of micturitions per 24 hours (based on a 3-day average) | — |
Countries
Germany, Sweden
Outcome results
None listed