The Efficacy and Safety of OM-89 in Patients With Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Unknown statusPhase 4NCT06345014
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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)
Study details
- 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)
- Conditions
- Interventions
- Drug: OM-89 [Uro-Vaxom® Capsule]
- Drug: OM-89 Placebo [Uro-Vaxom® Capsule Placebo]
- Sponsor
- AJU Pharm Co., Ltd.
- Collaborators
- OM Pharma SA
- Start date
- 2023-12-20
- Primary completion
- 2025-12-30
- Sex
- Male
- Age range
- from 19 Years to 55 Years
- Results posted
- No results posted in this snapshot
- Countries
- South Korea
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06345014