Status:
TERMINATED
Safety and Efficacy Study of Thalomid in Patients With Chronic Pancreatitis
Lead Sponsor:
Winthrop University Hospital
Collaborating Sponsors:
Celgene Corporation
Conditions:
Chronic Pancreatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 pancrea...
Eligibility Criteria
Inclusion
- 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
- 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- Patients will be withdrawn from the study at Visit 4 (Month 3) if pain score on VAS scale has not improved.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2007
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00469703
Start Date
August 1 2005
End Date
November 1 2007
Last Update
January 16 2008
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