A Research Study For People With Painful Diabetic Peripheral Neuropathy (DPN) is Now Enrolling

Description

The purpose of this study is to evaluate investigational tapentadol extended release (ER) when compared to placebo. Placebo is a dummy pill with no active drug, but looks like the real drug. Tapentadol is an opiod (narcotic) drug. Tapentadol immediate release (IR) has already been approved in does of 50, 75, and 100 mg for relief of moderate to severe pain. Participation in this 5-month study requires 14 office visits and 1 follow-up call. Researchers will be evaluating:

• How effectively it relieves pain
• Its safety profile
• If it causes any side effects

• You are 18 years of age or older
• You have a diagnosis of type 1 or type 2 diabetes mellitus
• You have painful diabetic peripheral neuropathy
• Your pain is not adequately controlled by standard therapies
• You have had persistent pain for longer than six months

• Will be reimbursed for study-related expenses
• Will be provided research-related medical care and medication at no cost

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 (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

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.

Details