The Efficacy and Safety of OM-89 in Patients With Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

332 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-20

Study Completion Date

2026-03-30

Brief Summary

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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)

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Detailed Description

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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

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Chronic Prostatitis With Chronic Pelvic Pain Syndrome Chronic Prostatitis Chronic Pelvic Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Background treatment - Xatral® XL Tab. 10 mg (alfuzosin hydrochloride): With the treatment of the investigational product, it will be administered for the first 13 weeks (Administration of the placebo will be continued to maintain the treatment compliance and blinding for the rest 13 weeks).

After week 13, Background treatment will be blinded for subject only until end of treatment period(Week 26).

Study Groups

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Study Drug: OM-89 (Uro-Vaxom® Capsule 60 mg (6 mg as a freeze-dried bacterial lysate))

\- 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.

Group Type EXPERIMENTAL

OM-89 [Uro-Vaxom® Capsule]

Intervention Type DRUG

Oral administration of the investigational product (OM-89 \[Uro-Vaxom® Capsule\] or the placebo) once a day

Comparator:

\- Placebo of Uro-Vaxom® Capsule Oral administration of the investigational product (OM-89 \[Uro-Vaxom® Capsule\] or the placebo) once a day.

Group Type PLACEBO_COMPARATOR

OM-89 Placebo [Uro-Vaxom® Capsule Placebo]

Intervention Type DRUG

Oral administration of the investigational product(Placebo of Uro-Vaxom® Capsule)

Interventions

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OM-89 [Uro-Vaxom® Capsule]

Oral administration of the investigational product (OM-89 \[Uro-Vaxom® Capsule\] or the placebo) once a day

Intervention Type DRUG

OM-89 Placebo [Uro-Vaxom® Capsule Placebo]

Oral administration of the investigational product(Placebo of Uro-Vaxom® Capsule)

Intervention Type DRUG

Other Intervention Names

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Test Group(OM-89 group) Placebo Group(OM-89 Placebo group)

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No