The Efficacy and Safety of OM-89 in Patients With Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome
- Conditions
- Chronic ProstatitisChronic Pelvic Pain SyndromeChronic Prostatitis With Chronic Pelvic Pain Syndrome
- Interventions
- Drug: OM-89 [Uro-Vaxom® Capsule]Drug: OM-89 Placebo [Uro-Vaxom® Capsule Placebo]
- Registration Number
- NCT06345014
- Lead Sponsor
- AJU Pharm Co., Ltd.
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 332
- Male adults aged ≥19 to ≤55 at the time of obtaining the written consent
- Those who have t pain or discomfort in the pelvic or genital area
- NIH-CPSI (the National Institutes of Health Chronic Prostatitis Symptom Index) ≥ 15 in total score
- voluntarily signed the informed consent form to participate in this study
- Prostate specific antigen (PSA) ≥ 4.0 ng/ml at Visit 1 (screening)
- Received a prostate biopsy, surgery, or treatment within 12 weeks before Visit 1 (screening)
- Past or current medical history as Herpes infection treatment within 1 year before the Screening,Treatment for genital infections or sexually transmitted diseases and History of urogenital tumors.
- Those who have a medication history of the drugs(Drugs or health functional food, Health functional foods that affect prostate function etc)or have a plan to receive them during the study at Visit 1
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Study Drug: OM-89 (Uro-Vaxom® Capsule 60 mg (6 mg as a freeze-dried bacterial lysate)) OM-89 [Uro-Vaxom® Capsule] - OM-89 (Uro-Vaxom® Capsule 60 mg (6 mg as a freeze-dried bacterial lysate)) Oral administration of the investigational product (OM-89 \[Uro-Vaxom® Capsule\] or the placebo) once a day. Comparator: OM-89 Placebo [Uro-Vaxom® Capsule Placebo] - Placebo of Uro-Vaxom® Capsule Oral administration of the investigational product (OM-89 \[Uro-Vaxom® Capsule\] or the placebo) once a day.
- Primary Outcome Measures
Name Time Method NIH-CPSI total score WEEK 4, 13, 26, 39, 52 National Institute of Health Chronic Prostatitis Symptom Index (Minimum Score = 0 to Maximum Score=43, Higher score means worse outcome)
- Secondary Outcome Measures
Name Time Method NIH-CPSI domain score WEEK 4, 13, 26, 39, 52 pain, urinary symptoms, and effect on quality of life (Higher score means worse outcome)
Subject and Investigator's Global Assessment WEEK 4, 13, 26, 39, 52 Subject and Investigator's Global Assessment (Higher score means worse outcome, Very dissatisfied=1 to very satisfied=5)
Trial Locations
- Locations (1)
AJU Pharm Co., Ltd.
🇰🇷Seoul, Korea, Republic of