Mast Cells in Male Pelvic Pain and and Lower Urinary Tract Dysfunction
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mast cell tryptase levels in expressed prostatic secretions
研究概览
简要总结
The objective of this study is to evaluate inhibition of mast cells and the histamine 1 receptor (H1R) for treatment of chronic prostatitis (CP) and chronic pelvic pain syndrome (CPPS).
详细描述
Chronic pelvic pain is a hallmark of patients with CPPS, a non-bacterial category of prostatitis that is a significant source of morbidity in men. The cause of CPPS is unknown and there is a lack of biomarkers for diagnosis of this syndrome. Research in animal models of CP/CPPS have pointed to a role for mast cells and their degranulation constituents including mast cell tryptase in the development of pelvic pain and lower urinary tract symptoms. This study aims to evaluate the ability of FDA approved and marketed drugs to inhibit the release of mast cell tryptase and to ameliorate symptoms in patients with CP/CPPS.
This is an open label study to evaluate the efficacy of Cromolyn Sodium Oral Solution and Cetirizine hydrochloride (tablet) in men with CP/CPPS to reduce mast cell tryptase levels in expressed prostatic fluids and to show improvement in symptoms of CP/CPPS. There is no control group for the study. The difference between pre- and post-treatment levels across individuals will be assessed.
The study will consist of 3 periods: the Screening Period (Days -7 to -1), the Treatment Period (Days 1 to 21), and the Follow-up Period (7 days) after the last dose at Day 21.
During screening, subjects will be admitted to the clinic, undergo specimen (Expressed prostatic secretions (EPS), urine and blood) collection and recording of their baseline questionnaire responses Subjects will provide a basic health history, including current general health, adverse events, medications or treatments within the past 5 years. A physical examination including vital heart rate, breathing rate, blood pressure, temperature, height, weight and body mass will be taken. Subsequently, EPS from eligible subjects will be collected by the clinical team and assayed for the levels of mast cell tryptase within 24 hours of sample collection at the screening visit. 20 subjects with elevated mast cell tryptase will be identified and will be eligible for receiving the study medication from the Investigational pharmacy at Northwestern University.
Eligible subjects will be required to take medication for days 1-21 (Week 1-3), record their symptom scores weekly using the NIH-CPSI, and record all safety related symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male ages 21-80 years old
- •Diagnosed with Category III Chronic Pelvic Pain Syndrome
- •Patients reporting pain or discomfort in any of the 8 domains of the NIH_ Chronic Prostatitis Symptom Index (NIH-CPSI).
- •CP/CPPS symptoms must have been present for the majority of the time during any 3 months in the previous 6 months.
- •Mast cell tryptase levels in EPS above a control threshold of 25ng/ml based on healthy men.
排除标准
- •Males <21 and >80 years old
- •Patients with a known hypersensitivity to cromolyn sodium or cetirizine hydrochloride
- •Patients with impaired renal or hepatic function.
- •Mast cell tryptase levels in EPS equal to or below a control threshold of 25ng/ml based on healthy men.
研究组 & 干预措施
Treatment arm
Treated arm with cromolyn sodium and cetirizine hydrochloride
干预措施: Cromolyn Sodium (Drug)
Treatment arm
Treated arm with cromolyn sodium and cetirizine hydrochloride
干预措施: Cetirizine Hydrochloride (Drug)
结局指标
主要结局
Mast cell tryptase levels in expressed prostatic secretions
时间窗: 3 weeks
Changes in Mast cell tryptase at the end of treatment compared to levels observed before administration of the study drug.
次要结局
- NIH-CPSI score(3 weeks)
- AUA-SI score(3 weeks)
研究者
Praveen Thumbikat
Professor
Northwestern University