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

Chronic Pelvic Pain Syndrome Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06345014
• Other study ID #: 23CP40803
• Status: Recruiting
• Phase: Phase 4
• Start date: December 20, 2023
• Est. completion date: March 30, 2026

Study information

• Verified date: April 2024
• Source: AJU Pharm Co., Ltd.
• Contact: JUNNGMIN LEE
• Phone: +82-02-2630-0700
• Email: ajuf13001[@]ajupharm.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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 information / eligibility

• Status: Recruiting
• Enrollment: 332
• Est. completion date: March 30, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Pelvic Pain Syndrome
• Chronic Prostatitis
• Chronic Prostatitis With Chronic Pelvic Pain Syndrome
• Pelvic Pain
• Prostatitis
• Somatoform Disorders
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	AJU Pharm Co., Ltd.	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
AJU Pharm Co., Ltd.	OM Pharma SA

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	NIH-CPSI domain score	pain, urinary symptoms, and effect on quality of life (Higher score means worse outcome)	WEEK 4, 13, 26, 39, 52
Secondary	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