Safety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH CHRONIC PANCREATITIS

Tanezumab is effective in reducing the pain associated with chronic pancreatitis.

On 23 Dec 2010 the FDA imposed a clinical halt for anti-NGF compounds due to safety reasons, ie, a case of osteonecrosis which occurred in relation to an anti-NGF compound of another company. All indications with the exception of Cancer Pain are affected resulting in termination of all studies in respective indications. Recruitment of Study A4091044 was stopped effective 27 Dec 2010. Two patients recruited so far did not receive further doses and were followed up for safety until LSLV on 22 Mar 2011.

Inclusion Criteria:

• Adult male or female
• Written informed consent
• Diagnosis of chronic pancreatitis based on imaging studies
• Persistent abdominal pain due to chronic pancreatitis
• Qualifying pain score during the pre-treatment period
• Willing to comply with study visit schedule and study requirements including for women of child-bearing potential or male patients with female partners of child-bearing potential, the use of 2 forms of birth control

Exclusion Criteria:

• Pregnant women, lactating mothers, women suspected of being pregnant and women who wish to become pregnant during the course of the study
• Chronic pancreatitis as a complication of pancreatic cancer or acute pancreatic duct obstruction
• Pancreatic surgery, lithotripsy or endoscopist decompression within 3 months
• History of alcoholism (within 1 year of screening) or concurrent alcohol abuse
• History of cancer in the past years
• Significant cardiac disease within 6 months
• History, diagnosis or signs and symptoms of significant neurologic disease
• Disqualifying laboratory values including Hepatitis B or C, HIV and drug test
• Other medical condition that may interfere with study endpoints or safety of the patient as determined by the Investigator
• Known history of rheumatoid arthritis
• Avascular necrosis of the bone
• History of trauma to a major joint Evidence of osteoarthritis