A Long-term Safety Study With Tapentadol ER and Oxycodone CR in Patients With Moderate to Severe Pain Due to Chronic, Painful Diabetic Peripheral Neuropathy (DPN)
Condition: Diabetic Neuropathy, Painful; Diabetic Polyneuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Polyneuropathies; Pain
Intervention: Tapentadol extended release (ER); Oxycodone controlled release (CR)
Intervention description: 100, 150, 200, 250 mg twice daily for 52 weeks; 20, 30, 40, 50 mg twice daily for 52 weeks
Intervention MeSH terms: Oxycodone; Tapentadol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic neuropathy; Painful; Polyneuropathy; Peripheral neuropathy

Summary:

      The purpose of this study is to evaluate the safety profile of orally administered tapentadol
      ER dosages of 100 to 250 mg twice daily in patients with chronic, painful diabetic peripheral
      neuropathy (DPN) over long-term exposure of up to 1 year.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Man or woman aged 18 years or older

          -  Patients with Type 1 or 2 diabetes mellitus must have a documented clinical diagnosis
             of painful diabetic peripheral neuropathy with symptoms and signs for at least 6
             months, and pain present at the time of screening

          -  Diagnosis must include pain plus reduction or absence of pin sensibility and/or
             vibration sensibility on Total Neuropathy Score - Nurse (TNSn) examination in lower
             and/or upper extremities at screening

          -  The investigator considers the patient's blood glucose to be controlled by diet, or
             hypoglycemics, or insulin for at least 3 months prior to enrolling in the study (this
             control should be documented by figures of glycated hemoglobin (HbA1c) no greater than
             11% at screening)

          -  Patients have been taking analgesic medications for the condition for at least 3
             months prior to screening (patients taking opioid analgesics must be dissatisfied with
             current treatment, and patients taking non-opioid analgesics must be dissatisfied with
             current analgesia)

          -  Patients currently requiring opioid treatment must be taking daily doses of an
             opioid-based analgesic equivalent to <=160mg of oral morphine

          -  Patients with baseline score for average pain intensity in the previous 24 hours of
             =>4 on the 11-point numerical rating scale (NRS) at the beginning of the titration
             period

        Exclusion Criteria:

          -  Significant pulmonary, gastrointestinal, endocrine, metabolic (except diabetes
             mellitus), neurological, psychiatric disorders (resulting in disorientation, memory
             impairment or inability to report accurately as in schizophrenia, Alzheimer's disease)

          -  History of moderate to severe hepatic impairment

          -  Severely impaired renal function

          -  Clinically significant laboratory abnormalities

          -  Clinically significant cardiac disease

          -  History of seizure disorder or epilepsy

          -  History of any other clinically significant disease that in the investigator's opinion
             may affect efficacy or safety assessments or may compromise patient safety during
             study participation.