A Study to Evaluate the Efficacy, Safety, and Tolerability of Tapentadol ER Compared With Placebo in Patients With Chronic, Painful Diabetic Peripheral Neuropathy
Condition: Diabetic Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Intervention: Tapentadol extended release (ER); Placebo
Intervention description: Type= range, unit= mg, number= 100 to 250, form= tablet, route= oral use. Tapentadol ER optimal dose ranging between 100 mg and 250 mg twice daily for 15 weeks.; Form= tablet, route= oral use. Matching placebo twice daily.
Intervention MeSH terms: Tapentadol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 460.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic Peripheral Neuropathy; Painful; Polyneuropathy; Peripheral neuropathy

Summary:

      The purpose of this study is to evaluate the efficacy, safety, and tolerability of orally
      administered tapentadol extended release (ER) at dosages of 100 to 250 mg twice daily
      compared with placebo in patients with moderate to severe pain due to chronic, painful
      diabetic peripheral neuropathy (DPN) who tolerated tapentadol (ER) and have an initial
      treatment effect (pain improvement) after a 3-week, open-label titration period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

          -  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

        Exclusion Criteria:

          -  Significant history of pulmonary, gastrointestinal, endocrine, metabolic (except
             diabetes mellitus), neurological, psychiatric disorders (resulting in disorientation,
             memory impairment or inability to report accurately as in schizophrenia)

          -  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