Exploratory Study of L.S.E.S.r. (PERMIXON® 160 mg Hard Capsule) Versus Tamsulosine LP Activity on Inflammation Biomarkers in the Treatment of Urinary Symptoms Related to BPH; a Multinational, Multicentric, Randomised, Double Blind Parallel-group Prospective Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 206
- 主要终点
- Change from baseline of Inflammation Biomarkers
研究概览
简要总结
Inflammation is reported as one of the most recent hypotheses to explain BPH. Recent published works pointed out that urine and serum markers could be used for detection of prostatic inflammation.
The aim of the study is to assess the activity on inflammation biomarkers (serum and urine inflammation markers) of Permixon® 160 mg hard capsule and Tamsulosine Arrow LP in the treatment of urinary symptoms related to BPH.
The potential links between serum and urinary markers of inflammation and BPH clinical symptoms at baseline and on treatment will be explored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patient
- •Between 45 and 85 years old.
- •Patient with bothersome lower urinary tract symptoms such as pollakiuria (daytime or night time), urgency, sensation of incomplete voiding, delayed urination or weak stream, existing for over 12 months
- •I-PSS ≥ 10 at selection visit and ≥ 12 at randomisation visit (visit 2)
- •Stable patient's disease at randomisation defined as an absolute difference of 2 or less on I-PSS between selection and randomisation visits (visit 1 and visit 2)
- •I-PSS QoL score ≥ 3 evaluated at selection and randomisation visits,
- •5 mL/s ≤ maximum urinary flow rate < 15 mL/s for a voided volume ≥ 150 mL and ≤ 500 mL evaluated at randomisation visit (2 measurements if necessary)
- •Prostatic volume ≥30 cm³ determined by transrectal ultrasound at randomisation visit (visit 2)
- •Serum total PSA at randomisation visit (visit 2) :
- •10 ng/mL and Prostate Specific Antigen (free) / Prostate Specific Antigen (total) ≥ 25% or negative prostate biopsy within the past 6 months prior to selection visit.
- •Patient able to understand and sign the informed consent and understand and fill in self-questionnaires
排除标准
- •Post-void residual urine volume > 200 mL (by suprapubic ultrasound) at randomisation visit (visit 2).
- •Urological history :
- •Urethral stricture disease and/or bladder neck disease
- •Active (at selection and randomisation visits) or recent (< 3 months) or recurrent urinary tract infection
- •Indication of BPH surgery
- •Stone in bladder or urethra
- •Acute or chronic (documented) prostatitis
- •Prostate and cancer cancer treated or untreated
- •Interstitial cystitis (documented by symptoms and/or biopsy)
- •Active upper tract stone disease causing symptoms
- •Patient with history of surgery of the prostate, bladder neck or pelvic region
- •Any local and/or systemic inflammation disorders at selection and randomisation visit
研究组 & 干预措施
Tested product
干预措施: Permixon® 160 mg (Drug)
Tested product
干预措施: Placebo matching Tamsulosine Arrow LP (Drug)
Comparator
干预措施: Tamsulosine Arrow LP (Drug)
Comparator
干预措施: Placebo matching Permixon® 160 mg (Drug)
结局指标
主要结局
Change from baseline of Inflammation Biomarkers
时间窗: Day 1 (baseline), Day 30, Day 90
"Inflammation biomarkers assay in patients suffering from Benign Prostatic Hyperplasia at Day 1, Day 30 and Day 90 : * Urine inflammation markers \[mRNA (messenger RiboNucleic Acid) and proteins\] on the first urine flow after digital rectal examination * Serum inflammation markers (C-Reactive Protein and Sedimentation Rate) "
次要结局
- Change from baseline of urinary symptoms(Day 1 (baseline), Day 30, Day 90)
- Change from baseline of quality of life(Day 1 (baseline), Day 30, Day 90)
- Change from baseline of sexual activity(Day 1 (baseline), Day 30, Day 90)
- Change from baseline of maximum urinary flow rate(Day 1 (baseline), Day 30, Day 90)
- Change from baseline of prostate volume(Day 1 (baseline), Day 30, Day 90)
- Change from baseline of post-void residual urine volume (PVR)(Day 1 (baseline), Day 30, Day 90)
- Number of adverse events(up to 90 days)