A randomized, double blind, multi-centered, placebo controlled study of Simvastatin in the treatment of idiopathic chronic pancreatitis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Change in the Izbicki pain score
研究概览
简要总结
Chronic Pancreatitis (CP) is a progressive inflammatory condition of a pancreas, arising from repeated episodes of acute pancreatitis (AP). Due to recurrent episodes of AP and chronic inflammation, endocrine and exocrine tissues of the pancreas damage resulting in endocrine and exocrine insufficiencies. Simvastatin is the most commonly prescribed 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor, which has a widely accepted tolerability profile. We propose to administer simvastatin 40 mg daily for 6 months in this study because of its Anti- inflammatory and Anti- fibrotic activity.It will Decrease the production of pro-inflammatory cytokines such as tumor necrosis factor alpha (TNF-a), interleukin 1 (IL-1) and interleukin 6 (IL-6). Also, By inhibiting the transforming growth factor β1 (TGF-β1) signaling pathways and interfere with pancreatic stellate cells activation through down regulation of Rho signaling pathways. Participants randomized to Simvastatin-treatment are expected to experience a greater decrease in Izbicki Pain score, improvement of quality of life, fewer episode of pancreatitis related readmissions, a greater decrease in pro-inflammatory and greater increase in anti-inflammatory markers, a greater decrease in fibrotic markers and greater increase in anti-fibrotic markers and a greater increase in fecal elastase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •At screening, Adult patients (>18 years of age, at the time of enrollment) with chronic pancreatitis (Cambridge grade 0 to III); and women of child-bearing potential having confirmed negative pregnancy test result prior to enrollment are eligible for the study.
排除标准
- •If the patients had major ductal abnormalities (Cambridge Grade IV) or complications of chronic pancreatitis
- •If there will be any evidence of complete pancreas divisum either by MRCP or ERCP.
- •If there will be a history of active malignancy or pancreatic surgery or chronic myopathy
- •If the patient had family history of pancreatitis or pancreatic cancer
- •Pregnant or breast feeding women
- •If patient had any other reversible etiology such as alcohol, smoking, hypertriglyceridemia, autoimmune pancreatitis.
结局指标
主要结局
Change in the Izbicki pain score
时间窗: 6 months
次要结局
- Change in levels of Fecal Elastase(6 months)
- Change in quality of life score as measured by the QLQ-C30 and QLQ-PAN28(CP)(6 months)
- Change in serum levels of CRP, IL-6, IL-10, TGF-β1,(MMP-9, TNF-α, ands-fractalkine)
- Change in pancreatitis-related hospital readmissions(6 months)