Status:
TERMINATED
Safety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis
Lead Sponsor:
Pfizer
Conditions:
Chronic Pancreatitis
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
Tanezumab is effective in reducing the pain associated with chronic pancreatitis.
Detailed Description
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 indi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 13 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2011
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01146561
Start Date
October 13 2010
End Date
March 22 2011
Last Update
March 23 2021
Active Locations (9)
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1
Gastroenterology Group-of Naples
Naples, Florida, United States, 34102-5449
2
Palm Beach Gastroenterology
Wellington, Florida, United States, 33414
3
Digestive Health Specialists
Tupelo, Mississippi, United States, 38801
4
North Mississippi Medical Center
Tupelo, Mississippi, United States, 38801