Safety and Efficacy Study of Thalomid in Patients With Chronic Pancreatitis

NCT00469703 | Terminated Phase 2

• 1 other identifier: Chronic Pancreatitis
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine if Thalidomide (Thalomid) is effective in treating patients with chronic pancreatitis.

Conditions

Chronic Pancreatitis

Keywords

Pancreatitis

Outcome Measures

Primary Outcomes (1)

• Safety and efficacy

Secondary Outcomes (3)

• reduction of frequency of hospitalizations

• quality of life

• reduction of pain

Interventions

Thalidomide DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Winthrop University Hospital: lead
• Celgene Corporation: collaborator

MeSH Terms

Conditions

Pancreatitis, Chronic; Pancreatitis

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• James H Grendell, MD

  Winthrop University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 3, 2007
• First Posted: May 4, 2007
• Study Start: August 1, 2005
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: January 16, 2008

Record last verified: 2008-01