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

Aju Pharm

Status and phase: Enrolling; Phase 4

Conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome; Chronic Prostatitis; Chronic Pelvic Pain Syndrome

Treatments: Drug: OM-89 [Uro-Vaxom® Capsule]; Drug: OM-89 Placebo [Uro-Vaxom® Capsule Placebo]

Study type: Interventional

Funder types: Industry

Identifiers

NCT06345014

23CP40803

Details and patient eligibility

About

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)

Full 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.

Enrollment: 332 estimated patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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332 participants in 2 patient groups, including a placebo group

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

Experimental group

Description:

- 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.

Treatment:

Drug: OM-89 [Uro-Vaxom® Capsule]

Comparator:

Placebo Comparator group

Description:

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

Treatment:

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