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临床试验/NCT02711943
NCT02711943已完成不适用

Non-interventional (Observational) Study of the Administration of Levolet® R, Film-coated Tablets (Dr. Reddy's Laboratories Ltd., India) in Adults With Chronic Prostatitis in Routine Clinical Practice

Dr. Reddy's Laboratories Limited0 个研究点目标入组 500 人开始时间: 2013年7月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
500
主要终点
Percentage of patients with response as per IMPSS scale

研究概览

简要总结

Chronic prostatitis is a common disease in men with the following typical symptoms decreasing the ability to work and quality of life: pain, urination disorders, copulatory dysfunction.

Following study is conducted to study Levofloxacin in chronic prostatitis.

详细描述

Chronic prostatitis is a common disease in men with the following typical symptoms decreasing the ability to work and quality of life: pain, urination disorders, copulatory dysfunction. Professional societies recommend diagnosing and treating patients with chronic prostatitis on the basis of determination of belonging to classification categories proposed by the National Institute of Diabetes and Digestive and Kidney Diseases and the National Institutes of Health in the USA .

According to the recommendations of European Association of Urologists, in chronic bacterial inflammation of the prostate and in nonbacterial (inflammatory syndrome of chronic pelvis pain), the performance of antibacterial therapy during four - six weeks is efficient. The first-line drugs are fluoroquinolones (ciprofloxacin and levofloxacin) as along with good tolerance they easily penetrate into the zones of the prostate inflammation and are highly efficient in respect of prostatitis pathogens . Although the treatment with levofloxacin promotes more evident decrease in clinical symptoms and demonstrates better parameters of eradication of pathogen in comparison with ciprofloxacin administration, it is used less common, possibly due to insufficient awareness of physicians of its high efficacy in chronic prostatitis .

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • male patients aged from 18 to 60 years, inclusive, with a diagnosis of the chronic prostatitis, which appointed the drug Levolet® P as a causal treatment.
  • Demonstrated sensitivity to levofloxacin abjection of chronic bacterial prostatitis.
  • The presence of a written informed consent to participate in research

排除标准

  • participation in another clinical study during the period of this study.

结局指标

主要结局

Percentage of patients with response as per IMPSS scale

时间窗: 28 days

Subjective evaluation of the treatment was performed using Integrative Medicine Patient Satisfaction Scale - IMPSS: completely satisfied, satisfied, neutral attitude, unsatisfied and extremely unsatisfied.

次要结局

  • Percentage of patients response as per IMOS(28 days)

研究者

申办方类型
Industry
责任方
Sponsor

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