A Study Of The Analgesic (Pain-Relief) Effects Of Tanezumab In Adult Patients With Diabetic Peripheral Neuropathy
Condition: Diabetic Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Intervention: Tanezumab; placebo
Intervention description: 20 mg subcutaneous injection every 8 weeks x 2 doses (at Baseline and week 8); Placebo to match tanezumab 20 mg subcutaneous injection every 8 weeks x 2 doses (at Baseline and week 8)
Intervention MeSH terms: Tanezumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: diabetic peripheral neuropathy; tanezumab; diabetic neuropathies; diabetic polyneuropathy; diabetic neuropathy painful

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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.