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Prulifloxacin in Chronic Bacterial Prostatitis (CBP)

NCT03201796 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2021-05-13

No results posted yet for this study

Summary

The aim of the study is to assess the efficacy and safety of prulifloxacin in comparison to levofloxacin in the treatment of patients affected by CBP.

Conditions

  • Chronic Bacterial Prostatitis

Interventions

DRUG

Prulifloxacin 600 mg

Oral administration of one tablet once daily for 28 days of prulifloxacin 600 mg. The investigational drug will be taken with a glass of water, preferably in the evening and at about the same time each day, 2 hours before or at least 4 hours after the eventual administration of cimetidine, antacids containing aluminum and magnesium or preparations containing iron and calcium.

DRUG

Levofloxacin 500mg

Oral administration of one tablet once daily for 28 days of levofloxacin 500 mg. The investigational drug will be taken with a glass of water, preferably in the evening and at about the same time each day, 2 hours before or at least 4 hours after the eventual administration of cimetidine, antacids containing aluminum and magnesium or preparations containing iron and calcium.

Sponsors & Collaborators

  • Hippocrates Research

    collaborator OTHER

  • Aziende Chimiche Riunite Angelini Francesco S.p.A

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-02
Primary Completion
2020-05-19
Completion
2020-05-19

Countries

  • Greece
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03201796 on ClinicalTrials.gov