Study of Ranexa in Patients With Coronary Artery Disease and Painful Polyneuropathy
Condition: Coronary Artery Disease; Pain; Peripheral Nervous System Diseases; Polyneuropathy
MeSH terms: Nervous System Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: Ranolazine; Placebo
Intervention description: Ranolazine ER tablet administered orally for 6 weeks (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks).; Placebo to match ranolazine administered twice a day for 6 weeks
Intervention MeSH terms: Ranolazine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Coronary Artery Disease; Pain; Peripheral Neuropathy; Polyneuropathy

Summary:

      This study was to determine whether ranolazine was effective in the treatment of neuropathic
      pain in patients with coronary artery disease.

      Eligibility required neurological examination by the study doctor and assessment of the
      patient's pain. Eligible participants were randomized to receive blinded study medication for
      a total of 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females aged ≥ 18 years

          -  Coronary artery disease with a clinically diagnosed peripheral neuropathy

          -  Willing and able to provide signed informed consent and Health Insurance Portability
             and Accountability Act (HIPAA) authorization

          -  Willing and able to comply with the requirements of the protocol and follow directions
             from the clinic staff

        Exclusion Criteria:

          -  History of allergy or intolerance to ranolazine

          -  Any condition or concomitant medication that would have precluded the safe use of
             ranolazine as outlined in the prescribing information sheet (see Appendix E)

          -  In the judgment of the investigator, any clinically-significant ongoing medical
             condition that might jeopardize the patient's safety or interfere with the absorption,
             distribution, metabolism or excretion of the study drug

          -  In the judgment of the investigator, clinically-significant abnormal physical findings
             during screening (excluding the patient's peripheral neuropathy condition)

          -  Use of any experimental or investigational drug or device within 30 days prior to
             screening

          -  Pregnant or breast feeding, or (if premenopausal), not practicing an acceptable method
             of birth control (as detailed in Inclusion Criterion 4)

          -  Had received prior treatment with, or investigational exposure to, ranolazine within 7
             days prior to randomization

          -  Clinically significant hepatic impairment

          -  Had end-stage renal disease requiring dialysis

          -  Psychological or addictive disorders (not limited to, but including drug and/or
             alcohol dependency) that may have precluded patient consent or compliance, or that may
             have confounded study interpretation

          -  Positive pregnancy test at Baseline (pre-randomization, Day 0)