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Safety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Naples, Florida, 34102-5449 United States
Contact
1-800-718-1021
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+ 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

NCT01146561
Pfizer
Terminated
Safety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis

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Safety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Of The Analgesic Efficacy And Safety Of Tanezumab In Patients With Chronic Pancreatitis
Tanezumab is effective in reducing the pain associated with chronic pancreatitis.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Chronic Pancreatitis
  • Biological: Tanezumab
    single administration of tanezumab 20 mg sub-cutaneously
  • Other: Placebo
    single administration of placebo to match tanezumab, sub-cutaneously
  • Experimental: Tanezumab 20 mg
    Intervention: Biological: Tanezumab
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
March 2011
March 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01146561
A4091044
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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