EUCTR2010-023775-25-DE进行中（未招募）不适用
A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel group, Adaptive, combined Proof of Concept and Dose-Finding study to investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP3652 in the treatment of CP/CPPS - AZURE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 350
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •At screening (Visit 1), the subject must:
- •1.have signed the informed consent
- •2.be male and 18 years of age or older
- •3.be diagnosed with CP/CPPS with moderate to severe disease activity (NIH-CPSI: total =15, question 4 =4)
- •4.symptoms arising from prostate or surrounding tissues/non-prostate structures
- •(pain on palpations and Yes” to at least 1 item from NIH-CPSI question 1 and 2)
- •At randomization (Visit 2), moderate/severe disease activity has to be confirmed
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •At screening (Visit 1), the subject must not have any of the following:
- •1.isolated unilateral testicular, penile or scrotal pain
- •2.urinary tract infection in the last 3 months before screening
- •3.any prior prostate and/or bladder intervention 3 months before screening
- •4.current urologic pathology; i.e., symptomatic urethral stricture, symptomatic bladder or ureteral calculi, lower urinary tract malignancy, severe bladder outlet obstruction, overactive bladder with incontinence, significant post void residual volume, clinically significant abnormalities on trans-abdominal ultrasound of bladder and prostate and/or neurologic disorder affecting bladder function
- •7.currently active sexually transmittable disease
- •8.history of, or known inflammatory bowel disease
- •9.severe fibromyalgia, severe irritable bowel syndrome and/or severe chronic fatigue syndrome
- •10.severe constipation and/or diarrhea, active diverticulitis and/or uninvestigated gastrointestinal bleeding
- •substance abuse (incl. alcohol), any use of THC / positive urine test for THC
研究者
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