Viokase 16, Viokase16 Plus Nexium and Nexium Alone
Chronic PancreatitisOur primary hypothesis is that the addition of Nexium to Viokase 16 will decrease the chronic abdominal pain in patients with small duct chronic pancreatitis in a superior fashion compared to Viokase 16 plus placebo or to Nexium alone. A secondary hypothesis would be an increase in quality of life. Our objective is to elucidate the role of Nexium in the control of pancreatic pain, quality of life, and narcotic usage alone or when added to Viokase 16. Our endpoints are the reduction of abdominal pain, decreased pain medication usage, decreased ER visits and decreased hospital admissions for abdominal pain.
Establishment and Verification of Pancreatic Volume Formula Based on Imaging
Healthy PeopleChronic Pancreatitis1 moreThis study intends to construct the linear relationship between pancreatic volume and individual attributes (height, weight, width of anterior superior iliac spine, etc.), and to establish and verify the formula of pancreatic volume.
Pentoxifylline Treatment in Acute Pancreatitis (AP)
Acute Pancreatitis (AP)Gallstone Pancreatitis7 moreThe purpose of this study was to determine the effects (good and bad) of giving a drug called pentoxifylline to patients with acute pancreatitis.
CPB Versus Sham Treatment for Pain Management in Small Duct Chronic Pancreatitis
Chronic PancreatitisThis study assesses the pain response to Endoscopic Ultrasound (EUS) guided Celiac Plexus Block (CPB) treatment in comparison to EUS without a pain block administered. All participants will receive medications for pain as needed.
Efficacy and Safety of Reparixin in Pancreatic Islet Auto-transplantation
Pancreatectomy for Chronic PancreatitisThe study is a phase 2/3, multicenter, double-blind, parallel assignment study. It involves 100 adult recipients of an intra-hepatic pancreatic Islet Auto-Transplantation (IAT). The objective of this clinical trial is to assess whether reparixin leads to improved transplant outcome as measured by the proportion of insulin-independent patients following IAT. The safety of reparixin in the specific clinical setting will be also evaluated.
A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency
Exocrine Pancreatic InsufficiencyChronic PancreatitisThis study is to verify the efficacy of 3.0 g/day of SA-001 in patients with pancreatic exocrine insufficiency caused by chronic pancreatitis in the non-compensatory stage or by pancreatectomy as compared with placebo under a double-blind design using the change in a coefficient of fat absorption as a primary endpoint.
A Open-label Study to Assess the Safety of Oral Long-term Use of SA-001 in Pancreatic Exocrine Insufficiency...
Pancreatic Exocrine InsufficiencyChronic Pancreatitis1 moreThis study is to evaluate the safety of 3.0 g/day of SA-001 (to be flexibly increased or decreased with the range from 1.5 g/day to 6.0 g/day), which will orally be administered for 52 weeks to patients with pancreatic exocrine insufficiency caused by chronic pancreatitis in the non-compensatory stage or by pancreatectomy.
Hydroxychloroquine and Metabolic Outcomes in Patients Undergoing TPAIT
Chronic PancreatitisInsulin Dependent DiabetesThis will be a pilot, 12-month phase II, open label, randomized, two-arm, single-blinded, placebo-controlled, parallel clinical trial of individuals undergoing TPAIT (Total Pancreatectomy and Autologous Islet Transplantation) for treatment of chronic pancreatitis (CP). The two study arms consist of HCQ-treated (Hydroxychloroquine) and placebo-treated individuals. The purpose of this study is to investigate the effects of HCQ administration compared to placebo on islet cell function post-autologous transplantation.
A Phase IIa Study With Escalating Dose of MS1819-SD
Chronic PancreatitisDistal PancreatectomyThis is a Phase IIa study sponsored by AzurRx SAS and Syneos Health is a local representative sponsor and involves testing of a new medication for the compensation of exocrine pancreatic insufficiency (EPI) caused by chronic pacreatitis (CP) and/or distal pancreatectomy. The new medication is called MS1819 Spray Dried (MS1819-SD) which is a lipase produced by the LIP2 gene of Yarrowia lipolytica using recombinant DNA technology. The primary purpose of this study is to investigate the safety of escalating doses of study drug MS1819-SD in people with chronic pancreatitis. This enzyme has demonstrated an appropriate profile to compensate the pancreatic lipase (enzyme) deficiency that is common with CP patients. The deficiency in this enzyme can be responsible of greasy diarrhea, fecal urge and weight loss. The design of the study is open-label, meaning that all eligible participants will receive the study drug MS1819-SD. The MS1819-SD dose will increase throughout the study during dose escalation visits in each treatment period; study includes a total of four treatment periods. The total duration of the MS1819-SD treatment phase is of 48-60 days, The total duration of patient participation in the study is of 74-93 days. Approximately twelve patients will be enrolled in this study.
Intravenous Lidocaine for Pain Associated With Pancreatic Cancer and Chronic Pancreatitis
Pancreatic CancerChronic PancreatitisPain is a major clinical problem for many patients with pancreatic cancer and chronic pancreatitis (CP).In pancreatic cancer, nearly 75% of patients suffer from pain at the time of diagnosis, with over 90% of patients in advanced stages. In CP, pain occurs in 80-90% of patients and strongly affects quality of life. For both conditions, the majority of pain is addressed using the WHO analgesic ladder. However, more invasive pain therapies are often necessary. Currently, in several centers in the Netherlands, treatment with IV lidocaine is already used in clinical practice in patients with pancreatic cancer and CP. Based on practical experience, the majority of patients benefit from this therapy, however, its efficacy in terms of duration of pain relief, decrease in pain scores, increase in patient satisfaction and adverse events is unknown. Therefore, the aim of this study is to investigate the efficacy of monitored single intravenous infusion in patients with pancreatic cancer and CP.