A Study Of The Analgesic (Pain-Relief) Effects Of Tanezumab In Adult Patients With Diabetic Peripheral Neuropathy

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Diabetic Peripheral Neuropathy

In brief

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.

Key facts

Study ID

NCT01087203

Run by

Pfizer

People needed

73

Starts

2010-03-30

Expected to finish

2011-07-06

Last updated by the study team

2021-02-24

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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