EUCTR2007-001214-16-GB进行中（未招募）1 期
A randomized, double blind, placebo controlled, parallel-group, multi-centre, Phase IIb, study to determine the effect of BXL628 in women with detrusor overactivity - BXL628 effect in OAB
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- BioXell SpA
- 入组人数
- 234
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •-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.
- •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
排除标准
- •-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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