Safety and Efficacy Study of Thalomid in Patients With Chronic Pancreatitis

• 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
• 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)

reduction of pain

quality of life

reduction of frequency of hospitalizations

Secondary ID(s)

Chronic Pancreatitis

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Celgene Corporation