Safety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01146561
First received: May 24, 2010
Last updated: August 23, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Chronic Pancreatitis
Biological: Tanezumab
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline in average chronic pancreatitis pain intensity score. [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in average chronic pancreatitis pain intensity score [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in worst chronic pancreatitis pain intensity score [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Brief Pain Inventory (BPI) -short form [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Patient's Global Assessment of Chronic Pancreatitis [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: No ]
  • Tanezumab levels in the plasma [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: Yes ]
  • Anti-tanezumab antibodies in the serum [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: Yes ]
  • Serum Nerve Growth Factor (NGF) levels [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: No ]
  • Safety laboratory [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: Yes ]
  • Adverse Events [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: Yes ]
  • ECG [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: October 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tanezumab 20 mg Biological: Tanezumab
single administration of tanezumab 20 mg sub-cutaneously
Placebo Comparator: Placebo Other: Placebo
single administration of placebo to match tanezumab, sub-cutaneously

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01146561

Locations
United States, Florida
Pfizer Investigational Site
Naples, Florida, United States, 34102-5449
Pfizer Investigational Site
Wellington, Florida, United States, 33414
United States, Mississippi
Pfizer Investigational Site
Tupelo, Mississippi, United States, 38801
United States, North Carolina
Pfizer Investigational Site
Harrisburg, North Carolina, United States, 28705
United States, Pennsylvania
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15261
United States, Wisconsin
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01146561     History of Changes
Other Study ID Numbers: A4091044
Study First Received: May 24, 2010
Last Updated: August 23, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Chronic
Digestive System Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on October 23, 2014