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

Study Overview
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Brief Summary
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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.

Official Title
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A Double-blind, Placebo-controlled, Cross-over Study of Ranolazine in Patients With Coronary Artery Disease for the Treatment of Painful Polyneuropathy

Conditions
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Coronary Artery Disease, Pain, Peripheral Nervous System Diseases, Polyneuropathy

Intervention / Treatment
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* Drug: Ranolazine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo-Ranolazine<br>Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6, then ranolazine during Weeks 7 to 12. | Drug: Ranolazine<br>* 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).<br>* Other names: Ranexa;Drug: Placebo<br>* Placebo to match ranolazine administered twice a day for 6 weeks<br>|
| Experimental: Ranolazine-Placebo<br>Participants were randomized to receive ranolazine during Weeks 1 to 6, then placebo to match ranolazine during Weeks 7 to 12. | Drug: Ranolazine<br>* 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).<br>* Other names: Ranexa;Drug: Placebo<br>* Placebo to match ranolazine administered twice a day for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Neuropathic Pain | Reduction in patient-reported neuropathic pain (by 2 numeric levels as measured by the Numeric Pain Scale) | Baseline to Week 6 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, Pain, Peripheral Neuropathy, Polyneuropathy