Safety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis
This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01146561
First received: May 24, 2010
Last updated: August 23, 2012
Last verified: August 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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:
Genetics Home Reference related topics:
hereditary pancreatitis
MedlinePlus related topics:
Pancreatitis
U.S. FDA Resources
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
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 Pancreatic Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013