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

Last updated: April 3, 2024
Sponsor: AJU Pharm Co., Ltd.
Overall Status: Active - Recruiting

Phase

4

Condition

Soft Tissue Infections

Dysmenorrhea (Painful Periods)

Interstitial Cystitis

Treatment

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

OM-89 [Uro-Vaxom® Capsule]

Study Drug

Clinical Study ID

NCT06345014
23CP40803
  • Ages 19-55
  • Male

Study 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)

Eligibility Criteria

Inclusion

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 intotal score
  • voluntarily signed the informed consent form to participate in this study

Exclusion

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 theScreening,Treatment for genital infections or sexually transmitted diseases andHistory 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 receivethem during the study at Visit 1

Study Design

Total Participants: 332
Treatment Group(s): 4
Primary Treatment: OM-89 Placebo [Uro-Vaxom® Capsule Placebo]
Phase: 4
Study Start date:
December 20, 2023
Estimated Completion Date:
March 30, 2026

Study 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.

Connect with a study center

  • AJU Pharm Co., Ltd.

    Seoul,
    Korea, Republic of

    Active - Recruiting

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