A Study Of The Analgesic (Pain-Relief) Effects Of Tanezumab In Adult Patients With Diabetic Peripheral Neuropathy
NCT ID: NCT01087203
Last Updated: 2021-02-24
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
73 participants
INTERVENTIONAL
2010-03-30
2011-07-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tanezumab
Tanezumab
20 mg subcutaneous injection every 8 weeks x 2 doses (at Baseline and week 8)
Placebo
placebo
Placebo to match tanezumab 20 mg subcutaneous injection every 8 weeks x 2 doses (at Baseline and week 8)
Interventions
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Tanezumab
20 mg subcutaneous injection every 8 weeks x 2 doses (at Baseline and week 8)
placebo
Placebo to match tanezumab 20 mg subcutaneous injection every 8 weeks x 2 doses (at Baseline and week 8)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of diabetic peripheral neuropathy pain in the legs or feet with decreased sensation in the feet or decreased/absent ankle jerk/ reflexes.
* Presence of ongoing pain due to diabetic peripheral neuropathy for at least 3 months.
* A pain score of greater than or equal to (≥) 4 for from diabetic peripheral neuropathy on the Numerical Rating Scale (NRS), a 11-point scale with 0 meaning no pain and 10 meaning worst pain at Screening.
* Be willing to stop all pain medications for diabetic peripheral neuropathy except for the limited use of acetaminophen (Tylenol) or ibuprofen-like (Motrin) medications between Screening and Baseline and not use prohibited pain medications throughout the duration of the study except as permitted by the study guidelines.
Exclusion Criteria
* Other types of diabetic neuropathies.
* Patients with a past history of carpal tunnel syndrome (CTS) with signs or symptoms of CTS in the one year prior to Screening are not eligible for participation.
* Patients with fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to severe pain.
* Patients with a present (current) history of sciatica are not eligible for participation.
* The presence of pain conditions that cannot be distinguished from diabetic peripheral neuropathy such as peripheral vascular disease.
* Amputations dues to diabetes.
* Patient with any clinically significant medical condition or laboratory abnormalities.
* History, diagnosis, or signs and symptoms of clinically significant neurological diseases (such as Alzheimer's disease, head trauma, epilepsy or stroke).
* History, diagnosis, or signs and symptoms of clinically significant psychiatric diseases (such as bipoar disorder or schizophrenia).
* History of known alcohol, analgesic or drug abuse within 2 years of Screening.
* Pregnant women, lactating mothers, women suspected of being pregnant, and women who wish to be pregnant during the course of clinical study.
18 Years
99 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Alabama Orthopaedic Clinic
Mobile, Alabama, United States
Coastal Clinical Research, Inc.
Mobile, Alabama, United States
Dedicated Clinical Research
Goodyear, Arizona, United States
Valley Radiology, Ltd.
Goodyear, Arizona, United States
Dedicated Clinical Research
Litchfield Park, Arizona, United States
Clinical Trials, Inc.
Little Rock, Arkansas, United States
Anaheim Hills MRI Holdings, Inc
Anaheim Hills, California, United States
Fullerton Neurology and Headache Center
Fullerton, California, United States
NervePro Medical Corporation
Irvine, California, United States
United Medical Imaging Healthcare (X-Ray Only)
Irvine, California, United States
Coordinated Clinical Research
La Jolla, California, United States
LabCorp (Draw blood only)
La Jolla, California, United States
Alpine Clinical Research Center, Inc
Boulder, Colorado, United States
JEM Research Institute
Atlantis, Florida, United States
Medical Specialists of the Palm Beaches
Atlantis, Florida, United States
Bradenton Research Center, Inc.
Bradenton, Florida, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, United States
SJS Clinical Research, Inc.
Destin, Florida, United States
White Wilson Medical Center
Fort Walton Beach, Florida, United States
MD Clinical
Hallandale, Florida, United States
Laszlo J. Mate, MD
North Palm Beach, Florida, United States
Palm Beach Neurological Center, Advanced Research Consultants, Inc.
Palm Beach Gardens, Florida, United States
Neurology Clinical Research, Inc.
Sunrise, Florida, United States
Neurology Specialists of Decatur Research Center
Decatur, Georgia, United States
Neurology Specialists of Decatur
Decatur, Georgia, United States
Allied Physicians Inc d/b/a Fort Wayne Neurology
Fort Wayne, Indiana, United States
American Health Network of IN, LLC
Greenfield, Indiana, United States
Radiology Department, American Health Network
Greenfield, Indiana, United States
Lee Research Institute
Lenexa, Kansas, United States
Mid-Atlantic Medical Research Centers
Hollywood, Maryland, United States
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, United States
Ozarks Community Hospital Christian County Clinic
Nixa, Missouri, United States
Clinvest/A Division of Banyan Group, Inc.
Springfield, Missouri, United States
Montana Neuroscience Institute Foundation
Missoula, Montana, United States
Asheville Neurology Specialists, PA
Asheville, North Carolina, United States
Joel Vandersluis, MD
Dayton, Ohio, United States
Hometown Urgent Care and Research
Dayton, Ohio, United States
Neurology and Neuroscience Center of Ohio
Toledo, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Mark A. Fisher M.D. -Private Practice
Oklahoma City, Oklahoma, United States
Westmoreland Neurology Associates, Inc
Greensburg, Pennsylvania, United States
The Neurology and Pain Clinic
Orangeburg, South Carolina, United States
Centex Research/Pineloch Medical Center
Houston, Texas, United States
Paragon Research Center, LLC
San Antonio, Texas, United States
Innovative Clinical Trials
San Antonio, Texas, United States
Daniel B. Vine, MD
Salt Lake City, Utah, United States
Wasatch Clinical Research
Salt Lake City, Utah, United States
RGL Medical Services
West Jordan, Utah, United States
Countries
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References
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Bramson C, Herrmann DN, Carey W, Keller D, Brown MT, West CR, Verburg KM, Dyck PJ. Exploring the role of tanezumab as a novel treatment for the relief of neuropathic pain. Pain Med. 2015 Jun;16(6):1163-76. doi: 10.1111/pme.12677. Epub 2015 Jan 16.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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DPN PHASE 2B
Identifier Type: OTHER
Identifier Source: secondary_id
A4091031
Identifier Type: -
Identifier Source: org_study_id
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