Phase III Clinical Trial to evaluate Efficacy, Safety and Tolerability of Fosfomycin (Trometamol) Powder 3 g versus Ciprofloxacin Tablets 750 mg in patients with Chronic Bacterial Prostatitis and Chronic Pelvic Pain Syndrome
Phase 3
- Conditions
- Health Condition 1: N411- Chronic prostatitis
- Registration Number
- CTRI/2022/08/045068
- Lead Sponsor
- SRS Pharmaceuticals Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Patients with history of chronic prostatitis and chronic [elvic pain syndrome
2.Current clinical signs and symptoms of chronic prostatitis and chronic pelvic pain syndrome.
3.Laboratory evidence of CBP at Screening visit
4.Willing to adhere to the prohibitions and restrictions specified in this protocol.
Exclusion Criteria
1.Known hypersensitivity or allergy to antibacterial fluoroquinolones or fosfomycin or to any components of the trial medications.
2.Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the screening assessment that could interfere with the objectives of the trial or the safety of the patient.
3.Patients with known history of prostatic absces
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method microbiological success in patients with chronic bacterial prostatitis and Chronic pelvic pain syndrome with Fosfomycin (Trometamol) Powder 3 g versus Ciprofloxacin Tablets 750 mg at the end of treatment when compared to the baseline values. Microbiological success is defined as a reduction of the bacteria to 103 CFU/ml post treatment with IMP(s) at end of treatment visit(s) when assessed by the 2-glass test.Timepoint: at end of treatment on day 42 for Fosfomycin (Trometamol) Powder 3 g and at end of treatment on day 28 for Ciprofloxacin Tablets 750 mg <br/ ><br>
- Secondary Outcome Measures
Name Time Method Proportion of patients with microbiological success for Fosfomycin (Trometamol) Powder 3 g as compared to Ciprofloxacin Tablets 750 mg on Day 7. <br/ ><br>Proportion of patients with microbiological success for Fosfomycin (Trometamol) Powder 3 g as compared to Ciprofloxacin Tablets 750 mg on Day 14. <br/ ><br>Proportion of patients with microbiological success for Fosfomycin (Trometamol) Powder 3 g as compared to Ciprofloxacin Tablets 750 mg on Day 28. <br/ ><br>Proportion of patients with microbiological success for Fosfomycin (Trometamol) Powder 3 g as compared to Ciprofloxacin Tablets 750 mg on TOC (at 5 to 18 days from EOT). <br/ ><br>Timepoint: Day 7, Day 14, Day 28 & EOT