Patients aged 18-75 years, of both sexes with symptoms of overactive bladder syndrome for at least 6 months. Lower level term (LLT): Overactive bladder (10059617) System Organ Class: Renal and Urinary Disorders Preferred term: Hypertonic bladder" MedDRA version: 7.1 Level: LLT Classification code 10059617
Conditions
Interventions
Product Name: not available
Product Code: KUC 7483
Pharmaceutical Form: Capsule*
INN or Proposed INN: n.a.
CAS Number: 476333-91-2
Current Sponsor code: KUC 7483
Concentration unit: mg milligram(s)
Co
Sponsors
Boehringer Ingelheim Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Urinary frequency of more or equal 8 micturitions/ 24 hours, Urgency and/or urge urinary incontinence episodes more or equal 1/24 hours Is a male or a female outpatient more or equal 18 years and less or equal 75 years of age. Has had symptoms of overactive bladder syndrome with symptoms of frequency, with or without nocturia, and urgency with or without urge urinary incontinence, for a minimum of 6 consecutive months prior to the study entry Has no language or cognitive barriers, Agrees to comply with the requirements of the protocol Has signed a written informed consent document prior to entry into the study. Is able to use a toilet independently and without difficulty. 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: Has known neurologic lesions or conditions (for example, multiple sclerosis, spinal cord lesions, Parkinson’s disease, myasthenia gravis) or local lesions (for example, bladder stones, tumours) that could cause the bladder overactivity Has incontinence with significant stress factor (>50% of incontinence episodes due to stress on the bladder diary collected at Visit 3) Has active or chronically recurring urinary tract infection (4 or more urinary tract infections per year) Had a lower urinary tract surgery within the past 6 months Has a significant haematuria (dipstick test ++ or +++) Has a current diagnosis of : a. urethral pain syndrome (defined by the ICS as an occurrence of recurrent episodic urethral pain usually on voiding, with daytime frequency and nocturia, in the absence of proven infection or other obvious pathology), b. interstitial cystitis, c. ureteric, bladder, urethral, or rectal fistula d. uncorrected congenital abnormality leading to urinary incontinence Has a current sign of significant vesical obstruction which in the opinion of the investigator could cause symptoms of urgency Has PVR volume = 100 mL within 15 minutes of a spontaneous void. Has a current diagnosis or a history of urogenital cancer Has a diagnosis of voluminous uterine fibroma or ovarian cyst which in the opinion of investigator could cause symptoms of urgency Had continence surgery including periurethral bulk injections or received bladder neck bulking agent therapy, including collagen injections for incontinence, within 6 months prior to Screening Visit (Visit 1) Began pelvic floor muscle exercises (for example, Kegel or biofeedback) or a behavioral bladder training program within 3 months prior to Screening Visit (Visit 1) Had previous pelvic irradiation Has indwelling catheter or intermittent catheterization Had received local administration of botulinium toxin within twelve months prior to Screening (Visit 1) Risk of increased bleeding or full anticoagulation. Is pregnant or nursing women Is a woman of childbearing potential (last menstruation equal or less 1 year prior to signing informed consent) not using a medically approved means of contraception for the previous three months (i.e. intra uterine device, oral contraceptives, diaphragm or subdermal implants) Has a current diagnosis of diabetes mellitus type I or II Has an history of myocardial infarction or any cardiac ischemic condition Has an history of known valvular disorders Has a tachycardia defined as heart rate at rest above 90 bpm measured twice at 15 to 30 minutes interval Has a symptomatic arrhythmia despite antiarrhythmic medication, uncontrolled angina, or a significant abnormality on ECG at Visit 1 that, in the opinion of the investigator, requires investigation or intervention Has a history of GI bleeding within the past 5 years or current evidence of GI bleeding (visible or positive FOB test), with the exception of hemorroids Has an inflammatory bowel disease, a Crohn disease, an ulcerative colitis, an oesophagitis, a gastritis or a peptic ulcer Has a history of and/or active significant alcohol or drug abuse Has taken an investigational drug within one month or six half-lives (whichever is greater) prior to Screening (Visit 1) Currently participates in another study Had previously been randomized in this study Has a significant disease other than OAB, which in the opinion of the investigator may either put the patient at risk because of participation in the study or whic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this trial is to investigate efficacy, safety and dose response relationship of different oral doses (40 mg, 80 mg and 160 twice daily and 160 mg once-daily) of KUC 7483 BS given over a 8 weeks period when compared to placebo in patients with overactive bladder.;Secondary Objective: 1. Other endpoints derived from bladder diary 2. Quality of life 3. Safety (details in section 5.2 of the protocol) 4. Population pharmacokinetic analysis of KUC 7322 ZW including exploratory covariate screening ;Primary end point(s): The primary efficacy endpoint will be the change from baseline to Visit 7 (week 8) in average number of micturitions per 24 hour period as recorded during a 7 day period in the bladder diary, compared to placebo. | — |
Countries
United Kingdom
Outcome results
None listed