Intraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo Control in Patients With Pancreatic Insufficiency
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Peak levels of three enzymes - lipase, amylase, and protease - each measured in U/ml will be outcomes
研究概览
简要总结
The purpose of this research study is to learn about the activity of oral Pancrecarb® (a pancreatic enzyme preparation which contains proteins that help to digest food), administered by mouth as a capsule filled with specially coated granules in patients taking exogenous pancreatic enzyme therapy. Specific enzymes activities will be determined from samples of stomach and intestinal fluids after a standard liquid meal.
详细描述
Purpose:
The purpose of this study is to assess the bioavailability of oral Pancrecarb® (exogenous pancreatic enzyme administered orally as a capsule filled with enteric coated granules) compared to placebo control in patients with pancreatic insufficiency. Lipase, amylase and protease activities will be determined from stomach and duodenal aspirates after standard meal stimulation.
Participants:
Patients with pancreatic insufficiency will be recruited as the study population.
Procedures (methods):
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Documented pancreatic enzyme insufficiency as determined by spot fecal elastase-1 (<75 mcg/g) at the time of screening
- •Required daily exogenous enzyme supplementation with commercially available pancreatic enzymes
- •≥ 18 years of age
- •Male and female subjects
- •Able to swallow capsules
- •Clinically stable with no evidence of an acute medical conditions
排除标准
- •History of fibrosing colonopathy in cystic fibrosis subjects
- •Current diagnosis or a history of distal intestinal obstruction syndrome (DIOS) in the past 4 months
- •Known contraindications, sensitivity or hypersensitivity to porcine pancreatic enzymes, benzocaine or similar products
- •Women with a positive serum beta-hCG at the time of screening or the day of the study (due to radiation exposure)
- •Liver disease
- •ALT or AST ≥ 3 time the upper limit of normal
- •Bilirubin ≥ 3 times the upper limit of normal
- •Acute pancreatitis or acute exacerbation of chronic pancreatitis within 90 days
- •Use of medications which affect with intestinal transit (example, narcotics, erythromycin, metoclopramide etc.)
- •Subjects receiving treatment with antacids, H2 receptor blockers, or proton pump inhibitors and unable to discontinue these within 72 hr prior to the study day
- •Diabetes mellitus
- •A medical condition which the investigator deems significant enough to interfere with the ability of the subject to participate in the intubation study or interfere with the assessment of enzyme bioavailability
- •Small bowel disease (i.e. celiac disease)
- •Lactose intolerance
- •History of gastric resection
研究组 & 干预措施
1
Pre-treatment vs. post-treatment-
In the first phase, before administration of the capsules and liquid diet, baseline gastric and duodenal secretions will be aspirated via the oro-enteric tube. Subjects will get 5 placebo capsules at Time=0 given orally with the liquid Lundh diet. Pancreato-biliary and duodenal secretions in the duodenal region will be aspirated continuously over the first 20 min. Gastric and duodenal fluids will be aspirated from 20-180 min at specified time points. Following a rest of 1 hour, the same process will be repeated with the drug capsules. At the end of the study the catheter will be removed and patient will be offered a meal.
干预措施: Pancrelipase (Drug)
结局指标
主要结局
Peak levels of three enzymes - lipase, amylase, and protease - each measured in U/ml will be outcomes
时间窗: Samples will be collected over two consecutive 3 hour study periods and sent for analysis
次要结局
未报告次要终点