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)

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)

Study Overview

• Status: Recruiting
• Conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome; Chronic Prostatitis; Chronic Pelvic Pain Syndrome
• Intervention / Treatment: Drug: OM-89 [Uro-Vaxom® Capsule]; Drug: OM-89 Placebo [Uro-Vaxom® Capsule Placebo]

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.

• Study Type: Interventional
• Enrollment (Estimated): 332
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: JUNNGMIN LEE; Phone Number: +82-02-2630-0700; Email: ajuf13001@ajupharm.co.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • AJU Pharm Co., Ltd.
    • Contact: JUNGMIN LEE; Phone Number: +82-02-2630-0700; Email: ajuf13001@ajupharm.co.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: OM-89 [Uro-Vaxom® Capsule]; Oral administration of the investigational product (OM-89 [Uro-Vaxom® Capsule] or the placebo) once a day; Other Names: Test Group(OM-89 group)
Placebo Comparator: Comparator: - Placebo of 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); Other Names: Placebo Group(OM-89 Placebo group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NIH-CPSI total score	National Institute of Health Chronic Prostatitis Symptom Index (Minimum Score = 0 to Maximum Score=43, Higher score means worse outcome)	WEEK 4, 13, 26, 39, 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NIH-CPSI domain score	pain, urinary symptoms, and effect on quality of life (Higher score means worse outcome)	WEEK 4, 13, 26, 39, 52
Subject and Investigator's Global Assessment	Subject and Investigator's Global Assessment (Higher score means worse outcome, Very dissatisfied=1 to very satisfied=5)	WEEK 4, 13, 26, 39, 52

Collaborators and Investigators

• Sponsor: AJU Pharm Co., Ltd.
• Collaborators: OM Pharma SA

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2023
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: March 24, 2024
• First Submitted That Met QC Criteria: April 1, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Chronic Prostatitis; Chronic Pelvic Pain Syndrome; CP/CPPS
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Disease; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Syndrome; Chronic Disease; Somatoform Disorders; Pelvic Pain; Prostatitis; Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Adjuvants, Immunologic; OM 89
• Other Study ID Numbers: 23CP40803

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No