A Phase 4 interventional study of OM-89 [Uro-Vaxom® Capsule] and OM-89 Placebo [Uro-Vaxom® Capsule Placebo] in Chronic Prostatitis With Chronic Pelvic Pain Syndrome, Chronic Prostatitis and Chronic Pelvic Pain Syndrome, sponsored by AJU Pharm Co., Ltd.. Recruiting at 1 site in Korea, Republic of. Open to male participants aged 19 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-04-04.
Sponsored by AJU Pharm Co., Ltd. · Phase 4, Interventional, and Treatment
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)
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.
88 studies on the registry are indexed under Prostatitis; 11 are open to participants now.
This study's planned enrollment of 332 is above the median of 60 across 73 interventional studies indexed under Prostatitis.
Browse Prostatitis studies →AJU Pharm Co., Ltd. is the lead sponsor of 21 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
- 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]
- 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]
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)
Oral administration of the investigational product(Placebo of Uro-Vaxom® Capsule)
Also known as: Placebo Group(OM-89 Placebo group)
NIH-CPSI total score
National Institute of Health Chronic Prostatitis Symptom Index (Minimum Score = 0 to Maximum Score=43, Higher score means worse outcome)
Time frame: WEEK 4, 13, 26, 39, 52
NIH-CPSI domain score
pain, urinary symptoms, and effect on quality of life (Higher score means worse outcome)
Time frame: WEEK 4, 13, 26, 39, 52
Subject and Investigator's Global Assessment
Subject and Investigator's Global Assessment (Higher score means worse outcome, Very dissatisfied=1 to very satisfied=5)
Time frame: WEEK 4, 13, 26, 39, 52
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