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

NCT06345014 | Recruiting Phase 4

• 1 other identifier: 23CP40803
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 1

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)

Conditions

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

Keywords

CP/CPPS; Chronic Prostatitis; Chronic Pelvic Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• NIH-CPSI domain score

  WEEK 4, 13, 26, 39, 52

• Subject and Investigator's Global Assessment

  WEEK 4, 13, 26, 39, 52

Study Arms (2)

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

EXPERIMENTAL

\- 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]

Comparator:

PLACEBO 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]

Interventions

OM-89 [Uro-Vaxom® Capsule] DRUG

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

Also known as: Test Group(OM-89 group)

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

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

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

Also known as: Placebo Group(OM-89 Placebo group)

Comparator:

Eligibility Criteria

• Age: 19 Years - 55 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AJU Pharm Co., Ltd.: lead
• OM Pharma SA: collaborator

Study Sites (1)

AJU Pharm Co., Ltd.

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Prostatitis

Interventions

OM 89

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

JUNNGMIN LEE

CONTACT

+82-02-2630-0700; ajuf13001@ajupharm.co.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: March 24, 2024
• First Posted: April 3, 2024
• Study Start: December 20, 2023
• Primary Completion: December 30, 2025
• Study Completion: March 30, 2026
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

KR (1)