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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00469703
Date of registration: 03/05/2007
Prospective Registration: No
Primary sponsor: Winthrop University Hospital
Public title: Safety and Efficacy Study of Thalomid in Patients With Chronic Pancreatitis
Scientific title: A Phase II, Open-Label, Single Center Pilot Study to Determine the Safety and Efficacy of THALOMID (Thalidomide) in Patients With Chronic Pancreatitis.
Date of first enrolment: August 2005
Target sample size: 10
Recruitment status: Terminated
URL:  http://clinicaltrials.gov/show/NCT00469703
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     James H Grendell, MD
Address: 
Telephone:
Email:
Affiliation:  Winthrop University Hospital
Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Chronic Pancreatitis
Intervention(s)
Drug: Thalidomide
Primary Outcome(s)
Safety and efficacy
Secondary Outcome(s)
quality of life
reduction of frequency of hospitalizations
reduction of pain
Secondary ID(s)
Chronic Pancreatitis
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Celgene Corporation
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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