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Clinical Trials/NCT02711943
NCT02711943
Completed
Not Applicable

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 sites500 target enrollmentJuly 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Prostatitis
Sponsor
Dr. Reddy's Laboratories Limited
Enrollment
500
Primary Endpoint
Percentage of patients with response as per IMPSS scale
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

Detailed Description

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 .

Registry
clinicaltrials.gov
Start Date
July 2013
End Date
March 2014
Last Updated
10 years ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Percentage of patients with response as per IMPSS scale

Time Frame: 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.

Secondary Outcomes

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

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