Safety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01146561
• Date of registration: 24/05/2010
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Safety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis
• Scientific title: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH CHRONIC PANCREATITIS
• Date of first enrolment: October 13, 2010
• Target sample size: 2
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01146561
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Pancreatitis

Intervention(s)

Biological: Tanezumab

Other: Placebo

Primary Outcome(s)

Change from baseline in average chronic pancreatitis pain intensity score. [Time Frame: Baseline, 8 weeks]

Secondary Outcome(s)

Change from baseline in Patient's Global Assessment of Chronic Pancreatitis [Time Frame: Baseline, 16 weeks]

Change from baseline in Brief Pain Inventory (BPI) -short form [Time Frame: Baseline, 16 weeks]

Change from baseline in worst chronic pancreatitis pain intensity score [Time Frame: Baseline, 16 weeks]

Safety laboratory [Time Frame: Baseline, 16 weeks]

Tanezumab levels in the plasma [Time Frame: Baseline, 16 weeks]

ECG [Time Frame: Baseline, 16 weeks]

Anti-tanezumab antibodies in the serum [Time Frame: Baseline, 16 weeks]

Serum Nerve Growth Factor (NGF) levels [Time Frame: Baseline, 16 weeks]

Adverse Events [Time Frame: Baseline, 16 weeks]

Change from baseline in average chronic pancreatitis pain intensity score [Time Frame: Baseline, 16 weeks]

Secondary ID(s)

2010-019012-21

CHRONIC PANCREATITIS POC STUDY

A4091044

Source(s) of Monetary Support

Please refer to primary and secondary sponsors