A Single-Center Prospective Randomized Placebo Controlled Trial of Pancreatic Enzyme Supplements (Pancrelipase) for Treating Pain in Patients With Chronic Pancreatitis
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in pain scores based on Izbicki self-assessment score
研究概览
简要总结
The study purpose is to characterize the effect of pancreatic enzyme supplementation on chronic pancreatitis type pain.
详细描述
Study Type: Interventional, randomized, double-blind, placebo-controlled, crossover design, efficacy study Intervention arm: Pancreatic enzyme replacement (Pancrelipase) with meals and snacks daily, for 4 weeks.
Placebo arm: Lactose placebo tablets with meals and snacks, for 4 weeks. Washout Phase: Weeks 4 to 6, there will be cessation of placebo or Pancrelipase use.
Crossover Phase: Weeks 6 to 10, initial placebo arm receives Pancrelipase, Pancrelipase arm receives placebo
Surveys - Izbicki score and PANQOLI assessment occur at Week 0, 4, 6, and 10. Narcotic and non-narcotic usage will also be noted at these intervals. Patient will also report the tobacco and alcohol use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic pancreatitis based on chronic pancreatitis-type pain > 6 months leading to impaired quality of life AND at least 1 of the following (27):
- •Confirmed diagnosis of hereditary pancreatitis (PRSS1 gene mutation)
- •History of recurrent acute pancreatitis (>1 documented episode of characteristic abdominal pain associated with diagnostic imaging and/or elevated serum amylase or lipase > 3 times upper limit of normal).
- •Pancreatic calcifications on CT scan
- •At least 2 of the following:
- •Endoscopic Ultrasound (EUS) with = or > 4 criteria for chronic pancreatitis (hyperechoic foci, strands, or ducts, lobulation, irregular duct margin, visible side - branches, calcifications, cysts, ductal dilatation) (28)
- •Ductal (changes in side branch morphology) or parenchymal (loss of T1 signal intensity) abnormalities on secretin enhanced Magnetic resonance cholangiopancreatography (MRCP)
- •Abnormal endoscopic pancreatic secretory function tests (HCO3 <= 75mmol/L at 30 or 45 minutes or <= 80mmol/L at 1 hour
- •Subjects are capable of informed consent
排除标准
- •Pregnancy
- •Lactation
- •Active acute pancreatitis or an episode of acute pancreatitis within 2 months of presentation for evaluation
- •Pancreatic cancer
研究组 & 干预措施
Intervention Arm
Pancreatic enzyme replacement (Pancrelipase) with meals and snacks daily, for 4 weeks.
干预措施: Pancrelipase (Drug)
Placebo Arm
Lactose placebo tablets with meals and snacks, for 4 weeks.
干预措施: placebo (Drug)
结局指标
主要结局
Change in pain scores based on Izbicki self-assessment score
时间窗: Measured at weeks 0,4,6 and 10
Difference in pain scores based on Izbicki self-assessment will be evaluated to determine if pancrelipase improves pain symptoms in patients with chronic pancreatitis
次要结局
- Quality of life(Pancreatic Quality of Life Instrument (PANQOLI) assessment at weeks 0, 4, 6 and 10)
- Change in Narcotic Use(0, 4, 6 and 10 weeks of treatment)
研究者
Timothy Gardner
Associate Professor of Medicine
Dartmouth-Hitchcock Medical Center