ACTRN12621000745842尚未招募1 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Preliminary Efficacy of SIR1-365 in Adult Men with Chronic Prostatitis/Chronic Pelvic Pain Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 60 Years（—）
- 性别
- Male
入选标准
- •1. Men 18 to 60 years of age at the time of signing the informed consent.
- •2. Patient has signed and dated the appropriate Informed Consent document.
- •3. Patient has pain or discomfort in the pelvic region for at least 3 months in the last 6 months, in the absence of a urinary tract infection or other pelvic/urological cause and have a physician diagnosis of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) based on NIH Classification System. If treated with antibiotics, symptoms persist.
- •4. Patient with NIH-CPSI score of at least 15 at screening,
- •5. Patient or female partner of patient must agree to use a reliable contraceptive method for sexual intercourse from Screening until at least 90 days after the last dose of study drug, unless they have been surgically sterilized (vasectomy) for a minimum of 6 months.
- •6. Patient agrees not to participate in another interventional study after signing the informed consent form and until the end of study (EoS) visit has been completed.
排除标准
- •1. Patient has experienced 2 or more UTI in the 12 months prior to screening and facultative Gram negative or enterococcus with a value of greater than or equal to 1000 colony forming units (CFU) /ml in mid-stream urine (VB2) in the last 3 months prior to screening.
- •2. Patient has a history of or currently has prostate, penile, testicular, bladder, or urethral cancer or has undergone pelvic radiation, systemic chemotherapy, or intravesical chemotherapy.
- •3. For patients with suspected lower urinary tract malignancy, investigator should make clinical determination based on patient’s overall profiles including positive (micro) hematuria in urine sediment or prostate specific antigen (PSA) >4 ng/mL.
- •4. Patient with currently active sexually transmittable disease.
- •5. Patient with symptomatic urethral stricture or symptomatic bladder or urethral calculi, severe bladder outlet obstruction, overactive bladder with incontinence or post void residual volume greater than 150 mL.
- •6. Patient has unilateral orchialgia without pelvic symptoms, or neurological disease or disorder affecting the bladder.
- •7. Patient has undergone transurethral prostatectomy, transurethral incision of the prostate, transurethral incision or resection of the bladder neck, transurethral microwave thermotherapy, transurethral needle ablation, balloon dilation of the prostate, open prostatectomy or any other prostate surgery or treatment such as cryotherapy or thermal therapy, or any prior prostate and/or bladder intervention within 3 months prior to screening.
- •8. Patient with clinically relevant abnormal urine or blood safety laboratory values or active hepatic and/or biliary disease (Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) should be >3 times the upper limit of normal, total bilirubin should be >2 times the upper limit of normal).
- •9. Patient has a history of moderate or severe hepatic impairment, severe renal sufficiency, severe or unstable cardiovascular (i.e. prolonged QT), respiratory, hematological, endocrinological, neurological or other somatic disorders, which will impact the safety and efficacy evaluation by investigator judgements.
- •10. Patient with initiation, discontinuation, or variation in the dose of antidepressants, alpha- blockers, 5-alpha reductase inhibitors, antimuscarinics, benzodiazepines, skeletal muscle relaxants, non-steroidal anti-inflammatory drugs, non-opioid analgesics and herbal therapies during the last 4 weeks before screening. Patients should continue these medications at the same stable dose throughout the study.
- •11. Patient has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.
- •12. Patient is taking any medicine that is mainly metabolized by CYP450 2C19. The investigator could provide an alternative medicine that is not mainly metabolized by CYP450 2C19.
- •13. Patient has a known or suspected hypersensitivity to SIR1-365 or any components of SIR1-365 tablets.
- •14. Patient has received any investigational drug within 30 days or 5 half-lives, whichever is longer, prior to screening.
- •15. Patient has any other condition, which makes the patient unsuitable for study participation by investigator’s judgement.
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