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)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 332
- 试验地点
- 1
- 主要终点
- NIH-CPSI total score
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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).
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Study Drug: OM-89 (Uro-Vaxom® Capsule 60 mg (6 mg as a freeze-dried bacterial lysate))
- 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.
干预措施: OM-89 [Uro-Vaxom® Capsule] (Drug)
Comparator:
- Placebo of Uro-Vaxom® Capsule Oral administration of the investigational product (OM-89 [Uro-Vaxom® Capsule] or the placebo) once a day.
干预措施: OM-89 Placebo [Uro-Vaxom® Capsule Placebo] (Drug)
结局指标
主要结局
NIH-CPSI total score
时间窗: 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)
次要结局
- NIH-CPSI domain score(WEEK 4, 13, 26, 39, 52)
- Subject and Investigator's Global Assessment(WEEK 4, 13, 26, 39, 52)