Evaluating OM-89 for treating recurrent chronic prostatitis and pelvic pain
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 testing if a new treatment called OM-89 can help men aged 19 to 55 with recurrent chronic prostatitis and pelvic pain feel better over the course of a year.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 332 (estimated) |
| Ages | 19 Years to 55 Years |
| Sex | Male |
| Sponsor | AJU Pharm Co., Ltd. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06345014 on ClinicalTrials.gov |
What this trial studies
This clinical study is a multicenter, randomized, placebo-controlled, double-blind phase 4 trial aimed at assessing the efficacy and safety of OM-89 (Uro-Vaxom® Capsule) in patients suffering from recurrent chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Eligible male participants aged 19 to 55 will be randomized to receive either the investigational product or a placebo for 26 weeks, alongside alfuzosin as a background treatment for the first 13 weeks. The study will monitor participants for efficacy and safety outcomes over a total duration of 52 weeks.
Who should consider this trial
Good fit: Ideal candidates are male adults aged 19 to 55 with significant pelvic or genital pain and a NIH-CPSI score of 15 or higher.
Not a fit: Patients with elevated PSA levels, recent prostate procedures, or a history of certain infections or tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients suffering from recurrent chronic prostatitis and pelvic pain.
How similar studies have performed: Other studies have shown promise with similar approaches, but this specific combination therapy is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seoul
- AJU Pharm Co., Ltd. — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Junngmin Lee
- Email: ajuf13001@ajupharm.co.kr
- Phone: +82-02-2630-0700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.