Safety and Efficacy Study of Thalomid in Patients With Chronic Pancreatitis
Primary Purpose
Chronic Pancreatitis
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Thalidomide
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pancreatitis focused on measuring Pancreatitis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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- Patients will be withdrawn from the study at Visit 4 (Month 3) if pain score on VAS scale has not improved.
Sites / Locations
Outcomes
Primary Outcome Measures
Safety and efficacy
Secondary Outcome Measures
reduction of frequency of hospitalizations
quality of life
reduction of pain
Full Information
NCT ID
NCT00469703
First Posted
May 3, 2007
Last Updated
January 10, 2008
Sponsor
Winthrop University Hospital
Collaborators
Celgene Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00469703
Brief Title
Safety and Efficacy Study of Thalomid in Patients With Chronic Pancreatitis
Official Title
A Phase II, Open-Label, Single Center Pilot Study to Determine the Safety and Efficacy of THALOMID (Thalidomide) in Patients With Chronic Pancreatitis.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Terminated
Why Stopped
Terminated
Study Start Date
August 2005 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Winthrop University Hospital
Collaborators
Celgene Corporation
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pancreatitis
Keywords
Pancreatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Primary Outcome Measure Information:
Title
Safety and efficacy
Secondary Outcome Measure Information:
Title
reduction of frequency of hospitalizations
Title
quality of life
Title
reduction of pain
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James H Grendell, MD
Organizational Affiliation
Winthrop University Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of Thalomid in Patients With Chronic Pancreatitis
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