NCT01087801已完成3 期
A Placebo Controlled, Double-Blind, Parallel, Multicenter Study of Synthetic Human Secretin (ChiRhoStim®) Administered Intravenously to Stimulate Exocrine Pancreas Fluid Secretion for Collection Via Endoscope and Laboratory Analysis of DNA Markers
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Endoscopic Sample
研究概览
简要总结
The following are the study hypothesis:
- Secretin administration compared to placebo will result in a statistically significantly greater percentage of collected fluid samples being predominantly of exocrine pancreas origin when samples are duodenal aspirates.
- Secretin administration compared to placebo will result in a statistically significantly greater percentage of collected fluid samples meeting the minimum specifications for use in the indicated laboratory test of DNA mutational analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, 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
- •Documented or suspected diagnosis of chronic pancreatitis or suspected diagnosis of pancreatic cancer.
- •Undergoing Endoscopic Procedure.
- •Age ≥ 18 years.
- •Willing and able to sign informed consent, meeting IRB guidelines.
- •Willing and able to meet all study requirements and obligations.
排除标准
- •Ongoing, active pancreatitis at the time of the procedure.
- •Known adverse reaction to secretin.
- •Recent (within one month) use of medication that can potentially cause pancreatitis, such as metronidazole, tetracycline, sulfonamides.
- •Use of anticholinergic medication within 7 days of study.
- •Pregnant women, nursing mothers, or women of childbearing potential not employing appropriate contraception. Acceptable methods of birth control are: intrauterine device, implantable progesterone device, progesterone intramuscular injection, oral contraceptive (started at least one month prior to Visit 1 and continuing for the duration of the trial), contraceptive patch, condoms with spermicide or abstinence.
- •Any medical condition which in the judgment of the Principal Investigator makes participation of the patient in the study medically unwarranted.
- •Known complete obstruction of the pancreatic duct.
- •Patients who have received an investigational product/drug or device within 30 days prior to Visit 1.
研究组 & 干预措施
ChiRhoStim
Active Comparator
Human Secretin for Injection
干预措施: ChiRhoStim (Drug)
Placebo
Placebo Comparator
Saline for Injection
干预措施: Placebo (Drug)
结局指标
主要结局
Endoscopic Sample
时间窗: First 5 minutes after treatment administration
Is Volume ≥ 3.5 mL Is HCO3 concentration ≥ 40 mEq/L Is DNA mutational analysis (K-ras-2 gene Fluorescence peak height ≥ 50 Relative Florescence Units panel assessable markers informative ≥ 8). (Note- The outcome value is boolean (yes or no) as an answer).
Volume of Fluid ≥ 3.5mL (Boolean Expression Evaluated as Yes or no).
时间窗: First 5 minutes after treatment administration
Volume of pancreatic fluid. The volume is the number of mL of pancreatic fluid.
次要结局
未报告次要终点
研究者
研究点 (1)
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