EUCTR2013-004653-25-DE进行中（未招募）1 期
Clinical trial for examination of efficacy and safety of ANGOCIN® Anti-Infekt N versus placebo in the continous prophylaxis of chronically recurring uncomplicated cystitis - ANGOPROH
Repha GmbH0 个研究点目标入组 224 人开始时间: 2014年2月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 224
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
- •- Outpatients suffering from acute uncomplicated cystitis during screening (visit 1), confirmed by positive urine culture (=10³ CFU/ml Urine)
- •- History of chronically recurring uncomplicated cystitis (including the current cystitis at least three within the last twelve months or at previous two within the previous two months)
- •- Negative urine culture for visit 2 (<10³ CFU/ml urine)
- •- No characteristic symptoms of an acute uncomplicated cystitis during randomisation (visit 3)
- •- Patients of both sexes aged = 18 years
- •- Patients having signed written informed consent
- •- The Patient is willing and able to complete his participation in the clinical trial and to comply with the instructions
- •CFU = Colony-forming units
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •- Presence of factors which could indicate a complicated urinary tract infection: body temperature above 38,0°C (fever), flank pain or painful renal bed
- •- Progression of infection proximal of urinary bladder or spreading of pathogens (pyelonephritis, urosepsis)
- •- Irritable bladder syndrome
- •- Known abnormalities or obstruction of the urinary tract
- •- History of surgery of the urinary tract
- •- Signs of restricted renal function
- •- Acute infections besides infections of the lower urinary tract
- •- Pretreatment of the acute urinary tract infection with antibiotics, herbal medicinal products or homeopathics
- •- Glomerulonephritis / interstitial nephritis or proteinuria
- •- Acute gastric ulcer or acute ulcer of duodenum
- •- Abnormal laboratory results clinically significant)
- •- Patients with permanent catheter
- •- Patients with risk factors for a more severe progression
- •- Intake of oral anticoagulants (Vitamin-K-antagonists; e.g. Phenprocoumon, Warfarin)
- •- Patients with organ transplantation within the previous 3 years
- •- Patients with malignant diseases within the previous 5 years
- •- Patients with HIV
- •- Pregnant or breast-feeding women or women planning to become pregnant; women capable of bearing children and not applying a highly effective contraception (Pearl Index <1)
- •- Patients with a medical condition or a situation which, in the opinion of the investigator, poses a significant risk to the patient or which could impair or considerably influence the results of the trial
- •- Known hypersensitivity to nasturtium, horseradish root or any excipient of the study medication
- •- Patients receiving a medicinal prophylaxis besides the study medication; the concomitant intake of herbal products with potential prophylactic efficacy, as for instance cranberry, dog rose or kidney and bladder tea, is also not allowed
- •- Simultaneous participation in another trial or participation in a clinical trial within the last 30 days before inclusion into this Trial
- •- Known abuse of medicinal products, alcohol or other drugs
- •- Serious diseases of the Psyche
- •- Persons which are institutionalised by regulatory or judicial decree
研究者
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