NCT01716104已完成3 期
Multicentric Double-blind Placebo-controlled Randomized Parallel-group Clinical Trial of Safety and Efficacy of Afalaza in Patients With Symptoms of Benign Prostatic Hyperplasia and Risk of Progression
Materia Medica Holding16 个研究点 分布在 2 个国家目标入组 260 人开始时间: 2012年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 16
- 主要终点
- Change in Total IPSS Scores (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline.
研究概览
简要总结
The purpose of this study is:
- To assess safety of Afalaza drug within 12 months in patients with symptoms of benign prostatic hyperplasia (BPH) and risk of progression.
- To assess efficacy of Afalaza drug within 12 months in patients with symptoms of benign prostatic hyperplasia and risk of progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients 45 to 60 y.o. inclusive with a documented diagnosis of Benign prostatic hyperplasia.
- •Lower urinary tract symptoms (LUTS) having been experienced for 3 months and longer.
- •Total IPSS score (International Prostate Symptome Score) of 8 to
- •Prostate volume of more than 30 cm
- •Maximal urinary flow rate of 10-15 mL/sec.
- •Micturition volume of 125-350 mL.
- •Residual volume of less than 100 mL.
- •Serum prostate-specific antigen (PSA) level of less than 4 ng/mL.
- •Use of and compliance with contraceptive methods during the trial and for 30 days upon completion of participation in the trial.
- •Presence of the patient's information sheet (informed consent form) for participation in the clinical trial.
排除标准
- •Invasive therapies for BPH including a transurethral prostatic resection, thermotherapy, microwave therapy, transurethral needle ablation, stenting, etc.
- •Malignant oncological disease of the urogenital system as well as malignancies of any other localization during last 5 years.
- •Acute urinary retention (AUR) within 3 months before inclusion in the trial.
- •Neurogenic dysfunctions and bladder ears.
- •Urinary stone disease.
- •Urethral stricture, bladder neck sclerosis.
- •History of operative aids for pelvic organs.
- •Urogenital infections in the phase of active inflammation.
- •Systematic administration of agents exhibiting effects on bladder function and urine production.
- •Exacerbation or decompensation of chronic diseases affecting the possibility of patients to participate in the clinical trial, including severe concurrent cardiovascular conditions and disorders of the nervous system, renal and hepatic insufficiency.
- •History of administration of testosterone 5-alpha-reductase inhibitors (finasteride, dutasteride).
- •History of polyvalent allergy.
- •Allergy/intolerance to any component of drug agents used in the therapy.
- •Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency.
- •Administration of drugs specified as "Prohibited concomitant therapy", within 3 months before enrollment.
- •Exacerbation or decompensation of chronic diseases affecting the possibility of patients to participate in the clinical trial.
- •Drug and alcohol consumption (over 2 alc. units daily), mental diseases. Legal incapacity or limited legal capacity.
- •Legal incapacitation or limited legal capacity.
- •Patients, who, in the investigator's opinion, will fail to observe the requirements during the trial or adhere to the studied drug administration procedure.
- •Participation in other clinical trials within 3 months before enrolment in this trial.
- •Presence of other factors, complicating the patient's participation in the trial (e.g., planned lengthy business and other trips).
- •A patient is a part of the center's research staff, taking a direct part in the trial, or an immediate family member of the investigator. Immediate family members are defined as spouses, parents, children or siblings, regardless of whether full blood or adopted.
- •The patient is employed with Scientific Production Firm Materia Medica Holding LLC, i.e. is the company's employee, part-time employee under contract, or appointed official in charge of the trial, or their immediate family.
研究组 & 干预措施
Afalaza (2 tablets twice a day)
Experimental
干预措施: Afalaza (Drug)
Placebo (2 tablets twice a day)
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Total IPSS Scores (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline.
时间窗: Baseline, 1, 3, 6 and 12 months
The International Prostate Symptom Score (IPSS) is based on the answers to 7 questions concerning urinary symptoms plus one question concerning quality of life (QoL). Each of the seven symptoms includes the assignment of scores from 0 to 5. The total score can therefore range from 0 to 35 points (asymptomatic to very symptomatic). The patient's quality of life (QoL) was evaluated separately in this clinical study.
次要结局
- Change in Total Value of Risk Factors for Progression (Total Score of IPSS, Prostate Volume, PSA Level, Maximum Urinary Flow Rate, Residual Urine Volume) Compared to Baseline(Baseline and 3, 6 and 12 months)
- Change in Maximum Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline(Baseline and 1, 3, 6 and 12 months)
- Change in Dynamics of Irritative Symptoms Evaluated by IPSS (International Prostate Symptome Score) After 1, 3, 6 and 12 Months Compared to Baseline(Baseline and 1, 3, 6, 12 months)
- Change in Average Urinary Flow Rate After 1, 3, 6 and 12 Months Compared to Baseline(Baseline and 1, 3, 6 and 12 months)
- Percent Change in Mean Values of Prostate Gland Volume at 3, 6 and 12 Months Compared to Baseline(Baseline and 3, 6 and 12 months)
- Number of Episodes of Acute Urinary Retention, Surgical Intervention During the Observation Period(12 months)
- Change in Mean Values of Micturition Volume at 3, 6 and 12 Months Compared to Baseline(Baseline and 3, 6 and 12 months)
- Change in the Mean Values of Residual Urine Volume at 3, 6 and 12 Months Compared to Baseline(Baseline and 3, 6 and 12 months)
- Change in Quality of Life (QoL Index of IPSS) at 3, 6 and 12 Months Compared to Baseline(Baseline and 3, 6 and 12 months)
研究者
研究点 (16)
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