Overactive Bladder (OAB) MedDRA version: 9.1 Level: LLT Classification code 10020853 Term: Hypertonic bladder
Conditions
Interventions
Product Code: BXL628
Pharmaceutical Form: Capsule, soft
Current Sponsor code: BXL628
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the
Sponsors
BIOXELL SPA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Women aged 18-75 years - Patients must have had symptoms of overactive bladder (OAB) for at least 6 months - Patients must exhibit all of the following symptoms during the three-day diary collecting period prior to start of treatment: frequency at least 8 times per 24 h, urgency at least once per 24 h with or without one episode of urge incontinence in 24h. - Urodynamically confirmed detrusor overactivity. A urodynamic evaluation dated within 6 months before the enrolment can be considered valid - Patients on anticholinergic /antispasmodic drugs for the treatment of OAB must discontinue this treatment at visit 1 (at least 14 days prior to visit 2). - Women of childbearing potential should use two well established contraceptive methods (e.g. contraceptive pill and condom, IUD and condom) or abstain from sexual intercourse - Patients must be capable of independent toileting - Ability to fully understand all study procedures and to provide written informed consent to study participation - Ability to comply with dosing and study visits scheduled for the duration of 1 month 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: - Patients with predominant stress incontinence - Patients with well established neurological disorder (e.g. Multiple Sclerosis, Parkinson?s disease, Alzheimer disease) - Patients with pelvic organ prolapse staged III or IV (ICS classification) - Patients who have undergone urogenital surgery such as hysterectomy less than 6 months prior to visit 1 - Painful bladder syndrome - Patients with clinically significant bladder outlet obstruction and/or patients with a post void residual volume (PVR) ultrasound result, greater than 100 ml - Patients with total daily volume greater than 2.8 l of voided urine - History of acute urinary retention or history of repeated catheterizations due to acute urinary retention within the 3 months prior to visit 1 - Patients who intend to start a bladder training programme while in the study - Patients with an indwelling catheter and patients practising intermittent self-catheterisation - Patients who have undergone bladder biopsy or any other minor pelvic surgical intervention less than 30 days prior to visit 1 - Bladder cancer - Patients with acute or recurrent urinary tract infection (UTI) and/or unexplained haematuria - Stone in the bladder or urethra and upper tract stone disease causing symptoms - Evidence of renal insufficiency (creatinine > 1.5 x upper limit of normal) - Evidence of hepatic disease (total bilirubin > 1.5 x upper limit of normal, or AST or ALT or alkaline phosphatase > 2 x upper limit of normal) - Patients with other clinically significant systemic diseases that may interfere with participation in this study - Patients who are abusers of alcohol and/or other drugs - History of disturbed calcium, phosphorus or magnesium metabolism - Patients with allergy, hypersensitivity or other medical contraindications to Vitamin D - Patients taking any of the following at any time during the study: Anticholinergic /antispasmodic drugs for the treatment of OAB; Calcitriol and other vitamin D analogs; Cholestiramine and other bile acid-binding resins; Cardiac glycosides; Drugs containing magnesium; Anticonvulsants; Estrogen treatment (unless started more than 2 months before randomization; estrogen containing oral contraceptives are allowed) - Patients who have received any investigational drug during the preceding 90 days or 5 times the plasma half-life (if known), whichever is longer, or who have previously participated in this trial - Patients unable and/or unlikely to comprehend and follow the study procedures and instructions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of BXL628 on the bladder volume at the first involuntary contraction following 4 weeks of treatment;Secondary Objective: To determine the effect of BXL628 on: - Symptom severity measured by a three-day micturition diary - Urodynamics: uroflowmetry and cystometry parameters (according to urodynamic procedures recommendation) - Patient?s perception of bladder condition - Safety and tolerability;Primary end point(s): Change from baseline in the bladder volume at the first involuntary contraction following 4 weeks of treatment. | — |
Countries
Estonia, Italy, Latvia, Lithuania, Netherlands, United Kingdom
Outcome results
None listed