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Safety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis

Primary Purpose

Chronic Pancreatitis

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tanezumab
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pancreatitis

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Gastroenterology Group-of Naples
  • Palm Beach Gastroenterology
  • Digestive Health Specialists
  • North Mississippi Medical Center
  • Carolinas Digestive Health Associates
  • Carolinas Digestive Health Associates
  • UMPC Division of Radiology
  • University of Pittsburgh Medical Center
  • Wisconsin Center for Advanced Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tanezumab 20 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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).
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).
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.
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.
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?".
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?".
Number of Participants With Anti Drug Antibody
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.
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).
Plasma Tanezumab Levels
Serum Nerve Growth Factor (NGF) Levels
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.
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.
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.

Full Information

First Posted
May 24, 2010
Last Updated
February 25, 2021
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01146561
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description.
Study Start Date
October 13, 2010 (Actual)
Primary Completion Date
March 22, 2011 (Actual)
Study Completion Date
March 22, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pancreatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tanezumab 20 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Tanezumab
Intervention Description
single administration of tanezumab 20 mg sub-cutaneously
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
single administration of placebo to match tanezumab, sub-cutaneously
Primary Outcome Measure Information:
Title
Change From Baseline in Average Chronic Pancreatitis Pain Intensity Score Over the Period From Week 1 to Week 8
Description
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).
Time Frame
Baseline, Week 1 to 8
Secondary Outcome Measure Information:
Title
Change From Baseline in Average and Worst Chronic Pancreatitis Pain Intensity Score at Week 1, 2, 4, 6, 8, 12 and 16
Description
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).
Time Frame
Baseline, Week 1, 2, 4, 6, 8, 12, 16
Title
Change From Baseline in Worst Chronic Pancreatitis Pain Intensity Score Over Week 1 to Week 8 Period
Description
Daily average worst chronic pancreatitis pain is assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain).
Time Frame
Baseline, Week 1 to 8
Title
Number of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average and Worst Chronic Pancreatitis Pain Intensity Score
Description
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).
Time Frame
Week 8
Title
Number of Participants With Cumulative Reduction From Baseline in Average and Chronic Pancreatitis Pain Intensity Score
Description
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).
Time Frame
Week 8
Title
Change From Baseline in Brief Pain Inventory - Short Form (BPI-sf) Average and Worst Pain Score at Week 8 and 16
Description
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.
Time Frame
Baseline, Week 8, 16
Title
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
Description
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.
Time Frame
Baseline, Week 8, 16
Title
Change From Baseline in Patient's Global Assessment (PGA) of Chronic Pancreatitis at Week 4, 8 and 16
Description
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?".
Time Frame
Baseline, Week 4, 8, 12
Title
Number of Participants With Improvement of Greater Than or Equal to 2 Points From Baseline in Patient's Global Assessment (PGA) of Chronic Pancreatitis
Description
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?".
Time Frame
Weeks 4, 8, 16
Title
Number of Participants With Anti Drug Antibody
Time Frame
Baseline, Week 8, 16
Title
Neuropathy Impairment Score (NIS)
Description
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.
Time Frame
Baseline and Weeks 2, 4, 8, 16
Title
Number of Participants With Injection Site Reaction
Description
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).
Time Frame
Day 1 up to Week 16
Title
Plasma Tanezumab Levels
Time Frame
Baseline (pre-dose), Week 2, 4, 8, 16
Title
Serum Nerve Growth Factor (NGF) Levels
Time Frame
Baseline (pre-dose), Week 8, 16
Title
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
Baseline up to 112 days after the dose of study medication (up to 113 days)
Title
Number of Participants With Clinically Significant Laboratory Abnormalities
Description
Laboratory analysis included blood chemistry, hematology, urinalysis, pregnancy test, glycosylated hemoglobin levels (HbA1c levels) test and blood alcohol test.
Time Frame
Baseline up to Week 16
Title
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Description
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.
Time Frame
Baseline up to Week 16
Other Pre-specified Outcome Measures:
Title
Number of Participants With Subcutaneous Doses
Description
Number of participants who received the single dose of placebo are reported.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Gastroenterology Group-of Naples
City
Naples
State/Province
Florida
ZIP/Postal Code
34102-5449
Country
United States
Facility Name
Palm Beach Gastroenterology
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Digestive Health Specialists
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
North Mississippi Medical Center
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Carolinas Digestive Health Associates
City
Harrisburg
State/Province
North Carolina
ZIP/Postal Code
28075
Country
United States
Facility Name
Carolinas Digestive Health Associates
City
Harrisburg
State/Province
North Carolina
ZIP/Postal Code
28705
Country
United States
Facility Name
UMPC Division of Radiology
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Wisconsin Center for Advanced Research
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4091044&StudyName=Safety%20And%20Efficacy%20Of%20Tanezumab%20In%20Patients%20With%20Chronic%20Pancreatitis
Description
To obtain contact information for a study center near you, click here.

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Safety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis

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