Clinical trial NCT06345014: The Efficacy and Safety of OM-89 in Patients With Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Chronic Prostatitis
Chronic Pelvic Pain Syndrome
Keywords: CP/CPPS
Chronic Prostatitis
Chronic Pelvic Pain Syndrome
Lead sponsor: AJU Pharm Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: OM Pharma SA
First posted: 2024-04-03
Enrollment: 332
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: NIH-CPSI total score
timeFrame: WEEK 4, 13, 26, 39, 52
Secondary outcomes:
measure: NIH-CPSI domain score
timeFrame: WEEK 4, 13, 26, 39, 52
measure: Subject and Investigator's Global Assessment
timeFrame: WEEK 4, 13, 26, 39, 52
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: AJU Pharm Co., Ltd.
Study officials:
References: