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Safety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis

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ClinicalTrials.gov Identifier: NCT01146561
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : June 17, 2010
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment Phase
Chronic Pancreatitis Biological: Tanezumab Other: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Actual Study Start Date : October 13, 2010
Actual Primary Completion Date : March 22, 2011
Actual Study Completion Date : March 22, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
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




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

Secondary Outcome Measures :
  1. Change from baseline in average chronic pancreatitis pain intensity score [ Time Frame: Baseline, 16 weeks ]
  2. Change from baseline in worst chronic pancreatitis pain intensity score [ Time Frame: Baseline, 16 weeks ]
  3. Change from baseline in Brief Pain Inventory (BPI) -short form [ Time Frame: Baseline, 16 weeks ]
  4. Change from baseline in Patient's Global Assessment of Chronic Pancreatitis [ Time Frame: Baseline, 16 weeks ]
  5. Tanezumab levels in the plasma [ Time Frame: Baseline, 16 weeks ]
  6. Anti-tanezumab antibodies in the serum [ Time Frame: Baseline, 16 weeks ]
  7. Serum Nerve Growth Factor (NGF) levels [ Time Frame: Baseline, 16 weeks ]
  8. Safety laboratory [ Time Frame: Baseline, 16 weeks ]
  9. Adverse Events [ Time Frame: Baseline, 16 weeks ]
  10. ECG [ Time Frame: Baseline, 16 weeks ]


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01146561


Locations
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United States, Florida
Gastroenterology Group-of Naples
Naples, Florida, United States, 34102-5449
Palm Beach Gastroenterology
Wellington, Florida, United States, 33414
United States, Mississippi
Digestive Health Specialists
Tupelo, Mississippi, United States, 38801
North Mississippi Medical Center
Tupelo, Mississippi, United States, 38801
United States, North Carolina
Carolinas Digestive Health Associates
Harrisburg, North Carolina, United States, 28075
Carolinas Digestive Health Associates
Harrisburg, North Carolina, United States, 28705
United States, Pennsylvania
UMPC Division of Radiology
Pittsburgh, Pennsylvania, United States, 15213
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Wisconsin
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01146561     History of Changes
Other Study ID Numbers: A4091044
2010-019012-21 ( EudraCT Number )
CHRONIC PANCREATITIS POC STUDY ( Other Identifier: Alias Study Number )
First Posted: June 17, 2010    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases
Tanezumab
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs