Trials / Recruiting
RecruitingNCT06345014
The Efficacy and Safety of OM-89 in Patients With Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome
A Multicenter, Randomized, Placebo-controlled, Double-blind, Phase 4 Study to Evaluate the Efficacy and Safety of OM-89 in Patients With Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 332 (estimated)
- Sponsor
- AJU Pharm Co., Ltd. · Industry
- Sex
- Male
- Age
- 19 Years – 55 Years
- Healthy volunteers
- Not accepted
Summary
This study is planned to Evaluate the Efficacy and Safety of OM-89 in Patients with Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Detailed description
This clinical study is designed as a multicenter, randomized, placebo-controlled, double-blind, phase 4 study to evaluate the efficacy and safety of the combination therapy of Uro-Vaxom® Capsule and alfuzosin in patients with recurrent chronic prostatitis. Once a subject voluntarily gives written consent to participate in this study, a screening test will be conducted to evaluate their eligibility. Subjects determined to be eligible to participate in the study on Visit 2 (baseline) will be enrolled, randomized 1:1 either to the test group (OM-89 \[Uro-Vaxom® Capsule\]) or the control group (placebo of OM-89) and administered the investigational product for 26 weeks. In parallel, an alpha blocker (alfuzosin 10 mg) will be administered for the first 13 weeks as a background treatment, followed by the placebo of alfuzosin until Week 26. The efficacy and safety will be checked until Week 52 from the start of the treatment for all subjects.
Conditions
- Chronic Prostatitis With Chronic Pelvic Pain Syndrome
- Chronic Prostatitis
- Chronic Pelvic Pain Syndrome
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OM-89 [Uro-Vaxom® Capsule] | Oral administration of the investigational product (OM-89 \[Uro-Vaxom® Capsule\] or the placebo) once a day |
| DRUG | OM-89 Placebo [Uro-Vaxom® Capsule Placebo] | Oral administration of the investigational product(Placebo of Uro-Vaxom® Capsule) |
Timeline
- Start date
- 2023-12-20
- Primary completion
- 2025-12-30
- Completion
- 2026-03-30
- First posted
- 2024-04-03
- Last updated
- 2024-04-04
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT06345014. Inclusion in this directory is not an endorsement.