NCT00469703

Safety and Efficacy Study of Thalomid in Patients With Chronic Pancreatitis

A Phase II, Open-Label, Single Center Pilot Study to Determine the Safety and Efficacy of THALOMID (Thalidomide) in Patients With Chronic Pancreatitis.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Winthrop University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if Thalidomide (Thalomid) is effective in treating patients with chronic pancreatitis.

Detailed description

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.

Conditions

• Chronic Pancreatitis

Interventions

Type	Name	Description
DRUG	Thalidomide

Timeline

• Start date: 2005-08-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2007-05-04
• Last updated: 2008-01-16