Safety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Chronic Pancreatitis

Treatments: Other: Placebo; Biological: Tanezumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01146561

A4091044

2010-019012-21 (EudraCT Number)

CHRONIC PANCREATITIS POC STUDY (Other Identifier)

Details and patient eligibility

About

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

Full 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 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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2 participants in 2 patient groups, including a placebo group

Tanezumab 20 mg

Experimental group

Treatment:

Biological: Tanezumab

Placebo

Placebo Comparator group

Treatment:

Other: Placebo