Study of Ranexa in Patients With Coronary Artery Disease and Painful Polyneuropathy

Phase 4

Terminated

Conditions: Coronary Artery Disease
Polyneuropathy
Pain
Peripheral Nervous System Diseases

Brief 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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Placebo-Ranolazine	Placebo	Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6, then ranolazine during Weeks 7 to 12.
Placebo-Ranolazine	Ranolazine	Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6, then ranolazine during Weeks 7 to 12.
Ranolazine-Placebo	Placebo	Participants were randomized to receive ranolazine during Weeks 1 to 6, then placebo to match ranolazine during Weeks 7 to 12.
Ranolazine-Placebo	Ranolazine	Participants were randomized to receive ranolazine during Weeks 1 to 6, then placebo to match ranolazine during Weeks 7 to 12.

Primary Outcome Measures

Name	Time	Method
Reduction in Neuropathic Pain	Baseline to Week 6	Reduction in patient-reported neuropathic pain (by 2 numeric levels as measured by the Numeric Pain Scale)

Secondary Outcome Measures

Name	Time	Method
Response to Thermal and Mechanical Stimuli	Baseline to Week 6	The participant response to thermal and mechanical stimuli as measured by the Hargreaves and Von Frey tests
Assess Participant Quality of Life Utilizing the Short Form 36 Health Survey (SF-36v2) Questionnaire	Baseline to Week 6	The participant quality of life assessed utilizing the SF-36v2 questionnaire