Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Non Interventional Study of Levofloxacin in Chronic Prostatitis (Levolet-R)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02711943
Recruitment Status : Completed
First Posted : March 17, 2016
Last Update Posted : March 17, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

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.


Condition or disease Intervention/treatment
Chronic Prostatitis Drug: Levofloxacin 500

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 .

Layout table for study information
Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Levofloxacin 500
    Oral levofloxacin (Levolet®) at a dose of 500 mg once a day for 28 days
    Other Name: Levolet R


Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic prostatitis, age 18-60 years
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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Layout table for investigator information
Principal Investigator: IGOR A KORNEYEV Acad. I.P. Pavlov First Saint-Petersburg State Medical University
Layout table for additonal information
Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT02711943    
Other Study ID Numbers: DRL_RUS/MD/2013/PMS/LEVOLET R
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatitis
Chronic Disease
Prostatic Diseases
Disease Attributes
Pathologic Processes
Levofloxacin
Ofloxacin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors