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Safety and Efficacy Study of Thalomid in Patients With Chronic Pancreatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00469703
Recruitment Status : Terminated (Terminated)
First Posted : May 4, 2007
Last Update Posted : January 16, 2008
Sponsor:
Collaborator:
Celgene Corporation
Information provided by:
Winthrop University Hospital

Tracking Information
First Submitted Date  ICMJE May 3, 2007
First Posted Date  ICMJE May 4, 2007
Last Update Posted Date January 16, 2008
Study Start Date  ICMJE August 2005
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2007)
Safety and efficacy
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2007)
  • reduction of frequency of hospitalizations
  • quality of life
  • reduction of pain
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Thalomid in Patients With Chronic Pancreatitis
Official Title  ICMJE A Phase II, Open-Label, Single Center Pilot Study to Determine the Safety and Efficacy of THALOMID (Thalidomide) in Patients With Chronic Pancreatitis.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Pancreatitis
Intervention  ICMJE Drug: Thalidomide
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: May 3, 2007)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 18-75, inclusive.
  2. Female must be post menopausal (≥ 24 months without menses or surgically sterilized).
  3. Able to comprehend English.
  4. Chronic pancreatic pain lasting for more than 2 months.
  5. 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
  6. Subject must score at least 4 cm on the VAS scale during the 1-2 week lead-in-period.
  7. Patients must give written informed consent.
  8. Patients must be willing and able to comply with the FDA-mandated S.T.E.P.S.® program.

Exclusion Criteria:

  1. Female of child-bearing potential.
  2. Unable to comprehend English.
  3. Patients with diabetes requiring insulin.
  4. Evidence of gallstones on screening ultrasonography.
  5. Current alcohol abuse or addiction to opiate analgesics.
  6. Patients with existing peripheral neuropathy.
  7. Patients who are taking medications known to be associated with development of neuropathy: Amiodarone, hydralazine, perhexiline, vincristine, cisplatin, Metronidazole (Flagyl), Dapsone, Phenytoin and Disulfiram.
  8. 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.
  9. Patients with active alcoholic liver disease or elevated liver function >3Xs the upper limit of normal.
  10. Patients will be withdrawn from the study at Visit 4 (Month 3) if pain score on VAS scale has not improved.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00469703
Other Study ID Numbers  ICMJE Chronic Pancreatitis
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Winthrop University Hospital
Collaborators  ICMJE Celgene Corporation
Investigators  ICMJE
Principal Investigator: James H Grendell, MD Winthrop University Hospital
PRS Account Winthrop University Hospital
Verification Date January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP