Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Clinical Trial of the Efficacy and Safety of Raphamin in Prevention of the Recurrences of Chronic Bacterial Cystitis
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 415
- 试验地点
- 49
- 主要终点
- Time to the first recurrence of chronic bacterial cystitis
研究概览
简要总结
Clinical Trial of the Efficacy and Safety of Raphamin in Prevention of Recurrences of Chronic Bacterial Cystitis
详细描述
Trial design: double blind, placebo-controlled, randomized in parallel groups clinical trial.
The trial includes female outpatients aged 18 years or older with typical symptoms of chronic bacterial cystitis. The severity of typical symptoms of recurrence (exacerbation) should be 7 points or more according to the subscale "Typical symptoms" of the scale "Acute Cystitis Symptom Scale" (ACSS).
At Visit 1 (Day 1), after signing the patient information sheet and the informed consent form for participation in the clinical trial, complaints and medical history are collected, a physical examination is performed, and the severity of typical symptoms of cystitis is assessed using ACSS, collection of urine biosamples for urine analysis with microscopy and bacteriological examination (for identification the sensitivity of microorganisms to antibiotics), ultrasound examination of the urinary system (kidneys, bladder), and concomitant therapy is recorded.
Urinalysis, general and biochemical blood tests are planned in at least 190 patients.
If the patient meets inclusion criteria and does not meets exclusion inclusion criteria at Visit 1 (Day 1), the patient is randomized to one of two groups: patients of Group 1 take Phosphomycin (3 g once) and Raphamin according to the therapeutic and preventive regimen for 10 days; patients of Group 2 use Phosphomycin (3 g once) and Placebo according to the Raphamin regimen for 10 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18 years and older.
- •Patients with a confirmed diagnosis of chronic bacterial cystitis.
- •Patients with exacerbation of chronic cystitis based on typical symptoms of exacerbation of the disease with a severity of 7 points or more in accordance wuth ACSS.
- •The first 48 hours from the onset of exacerbation) of chronic bacterial cystitis.
- •Patients who agreed to use an acceptable method of contraception during the study (for women of reproductive potential).
- •Availability of a signed patient information sheet and informed consent form for participation in the clinical trial.
排除标准
- •Presence of urolithiasis, urinary tract obstruction, urothelial cancer, pelvic organ prolapse, neurogenic bladder disorders at the time of examination.
- •Presence of malignant neoplasms of the urinary tract, ureter stone, more than 50 ml of residual urine in the bladder, confirmed by ultrasound examination.
- •Suspicion of bladder tuberculosis.
- •Presence of indications for hospitalization due to a serious condition, macrohematuria, complicated cystitis.
- •Decompensation of diabetes mellitus, immunodeficiency of any etiology, malignant cancer of any localization, severe circulatory insufficiency (cardiovascular disease with functional class IV according to the classification of the New York Heart Association, 1964).
- •Unstable angina pectoris or myocardial infarction within the previous 6 months.
- •Chronic kidney disease (classes С3-5 А3).
- •Hepatic impairment (Child-Pugh class C).
- •Patients who require medicinal products prohibited for use in this study.
- •Exacerbation or decompensation of chronic conditions affecting the patient's ability to participate in the clinical trial.
- •Malabsorption syndrome, including congenital or acquired lactase deficiency or other disaccharidase insufficiency, galactosemia.
- •Hypersensitivity to any component of the medicinal products used in the treatment.
- •Pregnancy, breastfeeding; childbirth less than 3 months prior to study enrollment, unwillingness to comply with contraceptive methods during the study.
- •The medications listed in the Prohibited Concomitant Medication section were administered within 4 weeks prior to enrollment.
- •Patients who, from the investigator's point of view, will not comply with the observation requirements of the study or comply with the administration of the study drug.
- •History of mental diseases, alcoholism, or drug abuse that, in the investigator's opinion, may interfere with the successful completion of trial procedures.
- •Participation in other clinical trials within 3 months prior to enrollment.
- •The patient belongs to the investigational site personnel directly involved in the study, closest relatives of the investigator. The closest relatives are defined as spouse, parents, children or siblings, regardless of whether they are natural or adopted.
- •The patient works for the company OOO "NPF "MATERIA MEDICA HOLDING", being an employee of the company, a temporary contract worker or an appointed official responsible for performing the trial, or their close relative.
研究组 & 干预措施
Raphamin
Take orally, do not take with meals. Keep the tablets in the mouth until completely dissolved.
On the first day of treatment, 8 tablets are taken according to the following scheme: 1 tablet every 30 minutes in the first 2 hours (a total of 5 tablets in 2 hours), then during the same day another 1 tablet is taken 3 times at regular intervals. On the 2nd day and then take 1 tablet 3 times a day. The duration of treatment is 10 days.
干预措施: Raphamin (Drug)
Placebo
Take orally, do not take with meals. Keep the tablets in the mouth until completely dissolved. Placebo is administered according to the Raphamin regimen for 10 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to the first recurrence of chronic bacterial cystitis
时间窗: 6 months
Criteria for the diagnosis of chronic bacterial cystitis recurrence are typical symptoms of exacerbation (acute cystitis): frequent urination with small volumes of urine; urgent urination (a sudden and uncontrollable urge to pass urine; feeling pain or burning when passing urine; feeling of incomplete bladder emptying after urination; pain or uncomfortable pressure in the lower abdomen (above the pubis); possible presence of blood in the urine (especially towards the end of urination). Criteria for the diagnosis of chronic bacterial cystitis are 2 and more recurrences during previous 6 months or 3 and more recurrences during previous 12 months.
次要结局
- Percentage of patients with a reduction of recurrences of chronic bacterial cystitis(6 months)