A Safety and Efficacy Study for Tapentadol (CG5503) Extended Release for Patients With Painful Diabetic Peripheral Neuropathy
Condition: Diabetic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Intervention: CG5503; placebo
Intervention description: 100, 150, 200, 250 mg twice daily given for up to 15 weeks; matching placebo twice daily for 12 weeks
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: 395.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic neuropathy; Painful Diabetic Polyneuropathy; Polyneuropathy; Peripheral neuropathy

Summary:

      The purpose of this study is to evaluate the effectiveness (level of pain control) and safety
      of Tapentadol (CG5503) extended release (ER) (base) compared to placebo in patients with
      moderate to severe pain from diabetic peripheral neuropathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with Type 1 or Type 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

          -  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 <=160 mg of oral morphine

        Exclusion Criteria:

          -  No 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), or any other clinically significant disease that in the Investigator's
             opinion may affect efficacy or safety assessments or may compromise patient's safety
             during trial participation

          -  no history of moderate to severe hepatic impairment such as chronic hepatitis B or C,
             presence of active hepatitis B or C within the last 3 months or impaired hepatic
             function with ALT or AST greater than 3-fold ULN

          -  No patients with severely impaired renal function

          -  No laboratory values above or below limits of normal unless considered not clinically
             relevant by the Investigator

          -  No significant cardiac disease (e.g., unstable angina pectoris, angina pectoris
             Canadian Cardiovascular Society (CCS) class III-IV, acute myocardial infarction within
             the last 3 months, cardiac insufficiency New York Heart Association (NYHA) class
             III-IV) or significant vascular disease (e.g., peripheral arterial occlusive disease
             (PAOD) Fontaine class IIb-IV)

          -  no life-long history of seizure disorders or epilepsy