Safety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis

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NCT01146561

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Study Location
Gastroenterology Group-of Naples
Naples, Florida, 34102-5449, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Pancreatitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-99 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Chronic PancreatitisSafety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis
NCT01146561
  1. Naples, Florida
  2. Wellington, Florida
  3. Tupelo, Mississippi
  4. Tupelo, Mississippi
  5. Harrisburg, North Carolina
  6. Harrisburg, North Carolina
  7. Pittsburgh, Pennsylvania
  8. Pittsburgh, Pennsylvania
  9. Milwaukee, Wisconsin
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Safety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis
Official Title  ICMJE A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH CHRONIC PANCREATITIS
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Pancreatitis
Intervention  ICMJE
  • Biological: Tanezumab
    single administration of tanezumab 20 mg sub-cutaneously
  • Other: Placebo
    single administration of placebo to match tanezumab, sub-cutaneously
Study Arms  ICMJE
  • Experimental: Tanezumab 20 mg
    Intervention: Biological: Tanezumab
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 13, 2011)		2
Original Estimated Enrollment  ICMJE
 (submitted: June 16, 2010)		88
Actual Study Completion Date  ICMJE March 22, 2011
Actual Primary Completion Date March 22, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01146561
Other Study ID Numbers  ICMJE A4091044
2010-019012-21 ( EudraCT Number )
CHRONIC PANCREATITIS POC STUDY ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP