Chronic ProstatitisLevolet-RNCT02711943
Non Interventional Study of Levofloxacin in Chronic Prostatitis
An observational study of Chronic Prostatitis, run by Dr. Reddy's Laboratories Limited.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Chronic Prostatitis
- What is being tested?
- Levofloxacin 500
- Type of treatment
- Pill or oral medicine
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Study population: Patients with chronic prostatitis, age 18-60 years
Who may be able to join
- 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
Who cannot join
- participation in another clinical study during the period of this study.
About this study
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
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.
Read the 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 .
- Conditions
- Chronic Prostatitis
- Being tested
- Levofloxacin 500
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levofloxacin 500Drug
Also called Levolet R
Oral levofloxacin (Levolet®) at a dose of 500 mg once a day for 28 days
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with response as per IMPSS scale
Subjective evaluation of the treatment was performed using Integrative Medicine Patient Satisfaction Scale - IMPSS: completely satisfied, satisfied, neutral attitude, unsatisfied and extremely unsatisfied.
Measured: 28 days
Secondary outcomes (1)
Percentage of patients response as per IMOS
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)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startJul 2013
- Primary completionFeb 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic ProstatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- IGOR A KORNEYEV, Principal investigator, Acad. I.P. Pavlov First Saint-Petersburg State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711943
- Sponsor's protocol ID
- DRL_RUS/MD/2013/PMS/LEVOLET R
- Acronym
- Levolet-R
- Status last verified
- Mar 2016
- First submitted
- 14 Mar 2016
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02711943
- Acronym / sponsor ID
- Levolet-R / DRL_RUS/MD/2013/PMS/LEVOLET R
- Conditions
- Chronic Prostatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 17 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with chronic prostatitis, age 18-60 years
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- participation in another clinical study during the period of this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levofloxacin 500Also: Levolet ROral levofloxacin (Levolet®) at a dose of 500 mg once a day for 28 days | Drug | – |
Primary outcome
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.
1 secondary outcome
Percentage of patients response as per IMOS
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
- Individual participant dataSharing planned: No
Related trials for Chronic Prostatitis
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Enrolling by invitation
Pulsed Electromagnetic Versus Hydrotherapy on Chronic Pelvic Pain
Chronic Pelvic Pain Syndrome
Recruiting
Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain
Erectile Dysfunction Due to Arterial Insufficiency, Erectile Dysfunction
RecruitingObservational study
Genetic Study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Chronic Prostatitis (CP), Chronic Pelvic Pain Syndrome (CPPS)
Recruiting
Oxiblume:CoQ10 (Ralivia) Therapy for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Chronic Pelvic Pain Syndrome (CPPS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
IGOR A KORNEYEV principal investigator
Acad. I.P. Pavlov First Saint-Petersburg State Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Prostatitis, run by Dr. Reddy's Laboratories Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with response as per IMPSS scale (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2016.