Non Interventional Study of Levofloxacin in Chronic Prostatitis (Levolet-R)
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|ClinicalTrials.gov Identifier: NCT02711943|
Recruitment Status : Completed
First Posted : March 17, 2016
Last Update Posted : March 17, 2016
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.
|Condition or disease||Intervention/treatment|
|Chronic Prostatitis||Drug: Levofloxacin 500|
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 .
|Study Type :||Observational|
|Actual Enrollment :||500 participants|
|Official Title:||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|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||March 2014|
- Drug: Levofloxacin 500
Oral levofloxacin (Levolet®) at a dose of 500 mg once a day for 28 daysOther Name: Levolet R
- 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.
- Percentage of patients response as per IMOS [ Time Frame: 28 days ]Therapy results were evaluated using physician's opinion according to Integrative Medicine Outcome Scale - IMOS (complete recovery, significant improvement, insignificant to moderate improvement, no changes, deterioration)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02711943
|Principal Investigator:||IGOR A KORNEYEV||Acad. I.P. Pavlov First Saint-Petersburg State Medical University|