Chronic Pelvic Pain Syndrome, Chronic Prostatitis, Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Conditions
Keywords
CP/CPPS, Chronic Prostatitis, Chronic Pelvic Pain Syndrome
Brief 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)
Detailed 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.
Interventions
Oral administration of the investigational product (OM-89 \[Uro-Vaxom® Capsule\] or the placebo) once a day
DRUGOM-89 Placebo [Uro-Vaxom® Capsule Placebo]
Oral administration of the investigational product(Placebo of Uro-Vaxom® Capsule)
Sponsors
OM Pharma SA
AJU Pharm Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Background treatment - Xatral® XL Tab. 10 mg (alfuzosin hydrochloride): With the treatment of the investigational product, it will be administered for the first 13 weeks (Administration of the placebo will be continued to maintain the treatment compliance and blinding for the rest 13 weeks). After week 13, Background treatment will be blinded for subject only until end of treatment period(Week 26).
Intervention model description
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.
Eligibility
Sex/Gender
MALE
Age
19 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NIH-CPSI total score | WEEK 4, 13, 26, 39, 52 | National Institute of Health Chronic Prostatitis Symptom Index (Minimum Score = 0 to Maximum Score=43, Higher score means worse outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NIH-CPSI domain score | WEEK 4, 13, 26, 39, 52 | pain, urinary symptoms, and effect on quality of life (Higher score means worse outcome) |
| Subject and Investigator's Global Assessment | WEEK 4, 13, 26, 39, 52 | Subject and Investigator's Global Assessment (Higher score means worse outcome, Very dissatisfied=1 to very satisfied=5) |
Countries
South Korea
Contacts
Primary ContactJUNNGMIN LEE
Outcome results
None listed