E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020853 |
E.1.2 | Term | Hypertonic bladder |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the effect of BXL628 on the bladder volume at the first involuntary contraction following 4 weeks of treatment |
|
E.2.2 | Secondary objectives of the trial |
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メs perception of bladder condition
- Safety and tolerability |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 |
|
E.4 | Principal exclusion criteria |
- Patients with predominant stress incontinence
- Patients with well established neurological disorder (e.g. Multiple Sclerosis, Parkinsonメ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 |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline in the bladder volume at the first involuntary contraction following 4 weeks of treatment. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 11 |