E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Detrusor overactivity (overactive bladder) |
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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 | 10059617 |
E.1.2 | Term | Overactive bladder |
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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. The primary variable will be evaluated at visit 2 (if the evaluation has not been performed in the previous 6 months), and at visit 4. |
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E.2.2 | Secondary objectives of the trial |
To determine: - the effect of BXL628 on symptom severity measured by a three-day patient diary evaluated at visits 3 and 4 - the effect of BXL628 on urodynamic parameters evaluated at visits 2 and 4: Uroflowmetry and cystometry parameters (according to the urodynamic procedure recommendations) - Patient’s perception of bladder condition evaluated at visits 3 and 4 - The safety and tolerability of BXL628 will be evaluated by: • AE at visits 2, 3, 4 and 5 • blood tests at visits 2, 4 • calciuria, phosphaturia and creatininuria at visits 3 and 4 • ECG at visits 2 and 4 • vital signs at visit 1, 2, 3 and 4
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Women aged 18-75 years - Patients must have had symptoms of 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.
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E.4 | Principal 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 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 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 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 overactive bladder; 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 - Patients who intend to donate blood or blood products during the study or within one month following the completion of the study - Patients who are pregnant or lactating
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in bladder volume at first involuntary contraction from baseline compared to after 4 weeks treatment. |
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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 | Yes |
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 | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 26 |
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 | No |
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
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The end of the study is defined as the last visit of the last patient. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 11 |