A Phase II, Open-Label, Single Center Pilot Study to Determine the Safety and Efficacy of THALOMID (Thalidomide) in Patients With Chronic Pancreatitis.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 主要终点
- Safety and efficacy
研究概览
简要总结
The purpose of this study is to determine if Thalidomide (Thalomid) is effective in treating patients with chronic pancreatitis.
详细描述
Pancreatitis is an inflammation of the pancreas, a gland that lies behind the stomach. The inflammation may develop suddenly (acute pancreatitis) or over many years (chronic pancreatitis). The pancreas produces the hormones, insulin and glucagon to control metabolism. The hormones and enzymes flow from the pancreas through the pancreatic duct into the upper part of the small intestine.
Most chronic pancreatitis patients often experience chronic abdominal pain during the course of the disease. Thalidomide increased the production of interleukin-10 (IL-10), which is important in regulating intestinal inflammation. Thalidomide is approved by the Food and Drug Administration (FDA) for a leprosy skin condition, erythema nodosum lerosum (ENL), but not for the treatment of chronic pancreatitis. In this case it is considered experimental.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75, inclusive.
- •Female must be post menopausal (≥ 24 months without menses or surgically sterilized).
- •Able to comprehend English.
- •Chronic pancreatic pain lasting for more than 2 months.
- •History of chronic pancreatitis with pancreatic type pain confirmed by at least one of the following:
- •Histological confirmation
- •CT/MRI (including calcifications, dilated cuts, dilated MPD, and /or atrophy)
- •ERCP with Cambridge score of 2 or greater
- •Subject must score at least 4 cm on the VAS scale during the 1-2 week lead-in-period.
- •Patients must give written informed consent.
- •Patients must be willing and able to comply with the FDA-mandated S.T.E.P.S.® program.
排除标准
- •Female of child-bearing potential.
- •Unable to comprehend English.
- •Patients with diabetes requiring insulin.
- •Evidence of gallstones on screening ultrasonography.
- •Current alcohol abuse or addiction to opiate analgesics.
- •Patients with existing peripheral neuropathy.
- •Patients who are taking medications known to be associated with development of neuropathy: Amiodarone, hydralazine, perhexiline, vincristine, cisplatin, Metronidazole (Flagyl), Dapsone, Phenytoin and Disulfiram.
- •Patients who have pre-existing hypercoagulable state. Patients with a history of malignancy within the past 5 years, patients with a recent surgical procedure, patients with chronic immobilization causing blood stasis, patients with history of embolism or deep vein thrombosis, patients with extreme heart failure, and patients with a congenital disorder of the clotting cascade.
- •Patients with active alcoholic liver disease or elevated liver function >3Xs the upper limit of normal.
- •Patients will be withdrawn from the study at Visit 4 (Month 3) if pain score on VAS scale has not improved.
结局指标
主要结局
Safety and efficacy
次要结局
- reduction of frequency of hospitalizations
- quality of life
- reduction of pain