Safety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis
NCT ID: NCT01146561
Last Updated: 2021-03-23
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
2 participants
INTERVENTIONAL
2010-10-13
2011-03-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tanezumab 20 mg
Tanezumab
single administration of tanezumab 20 mg sub-cutaneously
Placebo
Placebo
single administration of placebo to match tanezumab, sub-cutaneously
Interventions
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Tanezumab
single administration of tanezumab 20 mg sub-cutaneously
Placebo
single administration of placebo to match tanezumab, sub-cutaneously
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
99 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Gastroenterology Group-of Naples
Naples, Florida, United States
Palm Beach Gastroenterology
Wellington, Florida, United States
Digestive Health Specialists
Tupelo, Mississippi, United States
North Mississippi Medical Center
Tupelo, Mississippi, United States
Carolinas Digestive Health Associates
Harrisburg, North Carolina, United States
Carolinas Digestive Health Associates
Harrisburg, North Carolina, United States
UMPC Division of Radiology
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States
Countries
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Related Links
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Other Identifiers
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2010-019012-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CHRONIC PANCREATITIS POC STUDY
Identifier Type: OTHER
Identifier Source: secondary_id
A4091044
Identifier Type: -
Identifier Source: org_study_id
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