Clinical trial NCT01146561: Safety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis
Official title: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH CHRONIC PANCREATITIS
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Chronic Pancreatitis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-06-17
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility 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

Primary outcomes:
measure: Change From Baseline in Average Chronic Pancreatitis Pain Intensity Score Over the Period From Week 1 to Week 8
timeFrame: Baseline, Week 1 to 8
Secondary outcomes:
measure: Change From Baseline in Average and Worst Chronic Pancreatitis Pain Intensity Score at Week 1, 2, 4, 6, 8, 12 and 16
timeFrame: Baseline, Week 1, 2, 4, 6, 8, 12, 16
measure: Change From Baseline in Worst Chronic Pancreatitis Pain Intensity Score Over Week 1 to Week 8 Period
timeFrame: Baseline, Week 1 to 8
measure: Number of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average and Worst Chronic Pancreatitis Pain Intensity Score
timeFrame: Week 8
measure: Number of Participants With Cumulative Reduction From Baseline in Average and Chronic Pancreatitis Pain Intensity Score
timeFrame: Week 8
measure: Change From Baseline in Brief Pain Inventory - Short Form (BPI-sf) Average and Worst Pain Score at Week 8 and 16
timeFrame: Baseline, Week 8, 16
measure: Change From Baseline in Brief Pain Inventory - Short Form (BPI-sf) Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and 16
timeFrame: Baseline, Week 8, 16
measure: Change From Baseline in Patient's Global Assessment (PGA) of Chronic Pancreatitis at Week 4, 8 and 16
timeFrame: Baseline, Week 4, 8, 12
measure: Number of Participants With Improvement of Greater Than or Equal to 2 Points From Baseline in Patient's Global Assessment (PGA) of Chronic Pancreatitis
timeFrame: Weeks 4, 8, 16
measure: Number of Participants With Anti Drug Antibody
timeFrame: Baseline, Week 8, 16
measure: Neuropathy Impairment Score (NIS)
timeFrame: Baseline and Weeks 2, 4, 8, 16
measure: Number of Participants With Injection Site Reaction
timeFrame: Day 1 up to Week 16
measure: Plasma Tanezumab Levels
timeFrame: Baseline (pre-dose), Week 2, 4, 8, 16
measure: Serum Nerve Growth Factor (NGF) Levels
timeFrame: Baseline (pre-dose), Week 8, 16
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 112 days after the dose of study medication (up to 113 days)
measure: Number of Participants With Clinically Significant Laboratory Abnormalities
timeFrame: Baseline up to Week 16
measure: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
timeFrame: Baseline up to Week 16
Other outcomes:
measure: Number of Participants With Subcutaneous Doses
timeFrame: Day 1
Locations:
city: Naples
country: United States
facility: Gastroenterology Group-of Naples
state: Florida
city: Wellington
country: United States
facility: Palm Beach Gastroenterology
state: Florida
city: Tupelo
country: United States
facility: Digestive Health Specialists
state: Mississippi
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Harrisburg
country: United States
facility: Carolinas Digestive Health Associates
state: North Carolina
city: Harrisburg
country: United States
facility: Carolinas Digestive Health Associates
state: North Carolina
city: Pittsburgh
country: United States
facility: UMPC Division of Radiology
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: