Study Stopped
See termination reason in detailed description.
A Study Of The Analgesic (Pain-Relief) Effects Of Tanezumab In Adult Patients With Diabetic Peripheral Neuropathy
A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PARALLEL GROUP, PROOF OF CONCEPT STUDY OF THE ANALGESIC EFFECTS OF TANEZUMAB IN ADULT PATIENTS WITH DIABETIC PERIPHERAL NEUROPATHY
2 other identifiers
interventional
73
1 country
48
Brief Summary
The purpose of this study is to determine the effectiveness and safety of the investigational drug, tanezumab, in adult patients with painful diabetic peripheral neuropathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2010
Shorter than P25 for phase_2
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2010
CompletedFirst Posted
Study publicly available on registry
March 16, 2010
CompletedStudy Start
First participant enrolled
March 30, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 18, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 6, 2011
CompletedResults Posted
Study results publicly available
February 24, 2021
CompletedFebruary 24, 2021
February 1, 2021
8 months
March 11, 2010
January 13, 2021
February 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16
Participants assessed their DPN pain during the past 24 hours using 11-point Numeric Rating Scale (NRS) with score range of 0 (no pain) to 10 ( worst possible pain). Baseline score was calculated as the mean of the average pain scores over the 3 days in the initial pain assessment period. The Week 16 value was the average DPN Pain score calculated for the 7 days prior to and including Day 113 (Week 16).
Baseline, Week 16
Secondary Outcomes (25)
Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 1, 2, 4, 6, 8, and 12
Baseline, Week 1, 2, 4, 6, 8, 12
Number of Participants With Cumulative Reduction From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16
Week 16
Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)
Week 1, 2, 4, 6, 8, 12, 16
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst and Average Pain Score at Week 8 and 16
Baseline, Week 8, 16
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Week 8 and 16: Last Observation Carried Forward (LOCF)
Baseline, Week 8, 16
- +20 more secondary outcomes
Other Outcomes (1)
Number of Participants With Subcutaneous Doses of Study Medication
Day 1 up to Week 8
Study Arms (2)
Tanezumab
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Diagnosis of diabetes mellitus (high blood sugar) with HbA1c levels of ≤11% at Screening, and on a stable anti-diabetic medication regimen for the 30 days prior to randomization.
- 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.
You may not qualify if:
- Painful neuropathies other than diabetic peripheral neuropathy.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (48)
Alabama Orthopaedic Clinic
Mobile, Alabama, 36608, United States
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608, United States
Dedicated Clinical Research
Goodyear, Arizona, 85395, United States
Valley Radiology, Ltd.
Goodyear, Arizona, 85395, United States
Dedicated Clinical Research
Litchfield Park, Arizona, 85340, United States
Clinical Trials, Inc.
Little Rock, Arkansas, 72205, United States
Anaheim Hills MRI Holdings, Inc
Anaheim Hills, California, 92807, United States
Fullerton Neurology and Headache Center
Fullerton, California, 92835, United States
NervePro Medical Corporation
Irvine, California, 92618, United States
United Medical Imaging Healthcare (X-Ray Only)
Irvine, California, 92618, United States
Coordinated Clinical Research
La Jolla, California, 92037, United States
LabCorp (Draw blood only)
La Jolla, California, 92037, United States
Alpine Clinical Research Center, Inc
Boulder, Colorado, 80304, United States
JEM Research Institute
Atlantis, Florida, 33462, United States
Medical Specialists of the Palm Beaches
Atlantis, Florida, 33462, United States
Bradenton Research Center, Inc.
Bradenton, Florida, 34205, United States
Innovative Research of West Florida, Inc.
Clearwater, Florida, 33756, United States
SJS Clinical Research, Inc.
Destin, Florida, 32541, United States
White Wilson Medical Center
Fort Walton Beach, Florida, 32547, United States
MD Clinical
Hallandale, Florida, 33009, United States
Laszlo J. Mate, MD
North Palm Beach, Florida, 33408, United States
Palm Beach Neurological Center, Advanced Research Consultants, Inc.
Palm Beach Gardens, Florida, 33418, United States
Neurology Clinical Research, Inc.
Sunrise, Florida, 33351, United States
Neurology Specialists of Decatur Research Center
Decatur, Georgia, 30033, United States
Neurology Specialists of Decatur
Decatur, Georgia, 30033, United States
Allied Physicians Inc d/b/a Fort Wayne Neurology
Fort Wayne, Indiana, 46805, United States
American Health Network of IN, LLC
Greenfield, Indiana, 46140-2834, United States
Radiology Department, American Health Network
Greenfield, Indiana, 46140-2834, United States
Lee Research Institute
Lenexa, Kansas, 66215, United States
Mid-Atlantic Medical Research Centers
Hollywood, Maryland, 20636, United States
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, 48104, United States
Ozarks Community Hospital Christian County Clinic
Nixa, Missouri, 65714, United States
Clinvest/A Division of Banyan Group, Inc.
Springfield, Missouri, 65807, United States
Montana Neuroscience Institute Foundation
Missoula, Montana, 59802, United States
Asheville Neurology Specialists, PA
Asheville, North Carolina, 28806, United States
Joel Vandersluis, MD
Dayton, Ohio, 45417, United States
Hometown Urgent Care and Research
Dayton, Ohio, 45432, United States
Neurology and Neuroscience Center of Ohio
Toledo, Ohio, 43623, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Mark A. Fisher M.D. -Private Practice
Oklahoma City, Oklahoma, 73112, United States
Westmoreland Neurology Associates, Inc
Greensburg, Pennsylvania, 15601-2234, United States
The Neurology and Pain Clinic
Orangeburg, South Carolina, 29118, United States
Centex Research/Pineloch Medical Center
Houston, Texas, 77062, United States
Paragon Research Center, LLC
San Antonio, Texas, 78205, United States
Innovative Clinical Trials
San Antonio, Texas, 78229, United States
Daniel B. Vine, MD
Salt Lake City, Utah, 84102, United States
Wasatch Clinical Research
Salt Lake City, Utah, 84107, United States
RGL Medical Services
West Jordan, Utah, 84084, United States
Related Publications (1)
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.
PMID: 25594611DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This study was terminated following a United States (US) Food and Drug Administration (FDA) partial clinical hold.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2010
First Posted
March 16, 2010
Study Start
March 30, 2010
Primary Completion
November 18, 2010
Study Completion
July 6, 2011
Last Updated
February 24, 2021
Results First Posted
February 24, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share
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/data\_requests.