Safety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis
NCT01146561
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
- 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
- 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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| 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 |
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| Study Arms ICMJE |
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| 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 | 2 | ||||||
| Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| 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 |
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| Responsible Party | Pfizer | ||||||
| Study Sponsor ICMJE | Pfizer | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Pfizer | ||||||
| Verification Date | January 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||