The purpose of this trial is to determine if patients suffering from diabetic peripheral neuropathic pain treated with ranolazine will have a greater reduction in pain compared to placebo. Hypothesis: From the prior clinical observations, and analgesic efficacy in the preclinical animal model of neuropathic pain, the investigators hypothesize that subjects randomized to ranolazine will show a greater reduction in diabetic neuropathic pain compared to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
4
Oral administration, BID; for a maximum of 51 days.
Oral administration, BID; for a maximum of 51 days.
Cardiology Associates
Fairhope, Alabama, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
Cardiovascular Institute of the South
Lafayette, Louisiana, United States
Fifty percent or greater reduction in the mean Numeric Rating Scale (11-point NRS 0-10) recorded in the subjects' diaries from ranolazine compared to placebo.
Time frame: 6 weeks (42 Days)
Change in Quality of Life Assessment as measured by SF-36 v2
Time frame: Randomization (Day 0) and Day 42
Change in pain assessment measured by the Visual Analog Scale
Time frame: Randomization (Day 0), Day 14, Day 28, Day 42, and Day 56
Change in pain assessment measured by Short-Form McGill Pain Questionnaire
Time frame: Randomization (Day 0) and Day 42
Change in pain of patients with arterial ischemia measured by Short-Form McGill Pain Questionnaire
Pain reduction of ranolazine versus placebo in subjects with diabetic peripheral neuropathic pain (DPNP) and arterial ischemia compared to those with DPNP without arterial ischemia.
Time frame: Randomization (Day 0), Day 14, Day 28, Day 42, and Day 56
Additional pain medication
Additional pain medication after the baseline visit as needed for pain reduction in addition to the study drug.
Time frame: Randomization (Day 0), Day 14, Day 28, Day 42, and Day 56
Occurrence of Adverse Events after randomization
The rates and severity of Adverse Events (AEs) from Randomization (Day 0) through Termination (Day 56)
Time frame: 56 Days
Occurrence of Serious Adverse Events after randomization
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A serious adverse event (SAE), also may be called a serious adverse drug reaction, is any untoward medical occurrence that at any dose: * results in death, * is life-threatening, * requires inpatient hospitalization or prolongation of existing hospitalization, * results in persistent or significant disability/incapacity, or * is a congenital anomaly/birth defect.
Time frame: 56 Days