Safety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis

Chronic Pancreatitis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01146561
• Other study ID #: A4091044
• Secondary ID: 2010-019012-21CH
• Status: Terminated
• Phase: Phase 2
• Start date: October 13, 2010
• Est. completion date: March 22, 2011

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 22, 2011
• Est. primary completion date: March 22, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Pancreatitis
• Pancreatitis, Chronic

Intervention

Biological:
• Tanezumab
single administration of tanezumab 20 mg sub-cutaneously

Other:
• Placebo
single administration of placebo to match tanezumab, sub-cutaneously

Locations

Country	Name	City	State
United States	Carolinas Digestive Health Associates	Harrisburg	North Carolina
United States	Carolinas Digestive Health Associates	Harrisburg	North Carolina
United States	Wisconsin Center for Advanced Research	Milwaukee	Wisconsin
United States	Gastroenterology Group-of Naples	Naples	Florida
United States	UMPC Division of Radiology	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Digestive Health Specialists	Tupelo	Mississippi
United States	North Mississippi Medical Center	Tupelo	Mississippi
United States	Palm Beach Gastroenterology	Wellington	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Subcutaneous Doses	Number of participants who received the single dose of placebo are reported.	Day 1
Primary	Change From Baseline in Average Chronic Pancreatitis Pain Intensity Score Over the Period From Week 1 to Week 8	Daily average chronic pancreatitis pain is assessed with an 11-point Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain).	Baseline, Week 1 to 8
Secondary	Change From Baseline in Average and Worst Chronic Pancreatitis Pain Intensity Score at Week 1, 2, 4, 6, 8, 12 and 16	Daily average chronic pancreatitis pain and worst chronic pancreatitis pain are assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain).	Baseline, Week 1, 2, 4, 6, 8, 12, 16
Secondary	Change From Baseline in Worst Chronic Pancreatitis Pain Intensity Score Over Week 1 to Week 8 Period	Daily average worst chronic pancreatitis pain is assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain).	Baseline, Week 1 to 8
Secondary	Number of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average and Worst Chronic Pancreatitis Pain Intensity Score	Daily average chronic pancreatitis pain and worst chronic pancreatitis pain are assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain).	Week 8
Secondary	Number of Participants With Cumulative Reduction From Baseline in Average and Chronic Pancreatitis Pain Intensity Score	Daily average chronic pancreatitis pain and worst chronic pancreatitis pain are assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain).	Week 8
Secondary	Change From Baseline in Brief Pain Inventory - Short Form (BPI-sf) Average and Worst Pain Score at Week 8 and 16	BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf are 4 questions that assess pain intensity (question 5 consists of 7 items that assess level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was answered on a scale ranging from 0 to 10; '0=No pain and 10=Pain as bad as you can imagine'. Measure were scored by item, with lower scores indicated less pain or pain interference.	Baseline, Week 8, 16
Secondary	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	BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf are 4 questions that assess pain intensity (worst, least, average, right now) and question 5 consisted of 7 items that assess level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was answered on a scale ranging from 0 to 10; '0=No pain and 10=Pain as bad as you can imagine'. Measure was scored by item, with lower score indicated less pain or pain interference. The 7 items in question 5 were averaged to obtain pain interference index, range: 0 to 10; higher score=greater impairment.	Baseline, Week 8, 16
Secondary	Change From Baseline in Patient's Global Assessment (PGA) of Chronic Pancreatitis at Week 4, 8 and 16	Patient's Global Assessment of Chronic Pancreatitis is a global evaluation that utilizes a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor) for the following question: "Considering all the ways your chronic pancreatitis affects you, how are you doing today?".	Baseline, Week 4, 8, 12
Secondary	Number of Participants With Improvement of Greater Than or Equal to 2 Points From Baseline in Patient's Global Assessment (PGA) of Chronic Pancreatitis	Patient's Global Assessment of Chronic Pancreatitis is a global evaluation that utilizes a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor) for the following question: "Considering all the ways your chronic pancreatitis affects you, how are you doing today?".	Weeks 4, 8, 16
Secondary	Number of Participants With Anti Drug Antibody		Baseline, Week 8, 16
Secondary	Neuropathy Impairment Score (NIS)	NIS: 74-item questionnaire assesses muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.	Baseline and Weeks 2, 4, 8, 16
Secondary	Number of Participants With Injection Site Reaction	Assessment of the injection site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).	Day 1 up to Week 16
Secondary	Plasma Tanezumab Levels		Baseline (pre-dose), Week 2, 4, 8, 16
Secondary	Serum Nerve Growth Factor (NGF) Levels		Baseline (pre-dose), Week 8, 16
Secondary	Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience; persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state.	Baseline up to 112 days after the dose of study medication (up to 113 days)
Secondary	Number of Participants With Clinically Significant Laboratory Abnormalities	Laboratory analysis included blood chemistry, hematology, urinalysis, pregnancy test, glycosylated hemoglobin levels (HbA1c levels) test and blood alcohol test.	Baseline up to Week 16
Secondary	Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities	All standard intervals (PR, QRS, QT, QT interval corrected for heart rate using Fridericia's formula [QTcF], QT interval corrected for heart rate using Bazett's formula [QTcB], RR intervals and heart rate) were analyzed for ECG abnormalities.	Baseline up to Week 16

External Links

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