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

Primary Purpose

Coronary Artery Disease, Pain, Peripheral Nervous System Diseases

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Ranolazine

Placebo

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Pain, Peripheral Neuropathy, Polyneuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Cardiovascular Institute of the South Clinical Research Corporation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Placebo-Ranolazine

Ranolazine-Placebo

Arm Description

Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6, then ranolazine during Weeks 7 to 12.

Participants were randomized to receive ranolazine during Weeks 1 to 6, then placebo to match ranolazine during Weeks 7 to 12.

Outcomes

Primary Outcome Measures

Reduction in Neuropathic Pain

Reduction in patient-reported neuropathic pain (by 2 numeric levels as measured by the Numeric Pain Scale)

Secondary Outcome Measures

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

Response to Thermal and Mechanical Stimuli

The participant response to thermal and mechanical stimuli as measured by the Hargreaves and Von Frey tests

Full Information

NCT ID

NCT00832572

First Posted

January 28, 2009

Last Updated

May 23, 2014

Sponsor

Gilead Sciences

1. Study Identification

Unique Protocol Identification Number

NCT00832572

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Terminated

Why Stopped

Lack of enrollment

Study Start Date

January 2009 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gilead Sciences

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Coronary Artery Disease, Pain, Peripheral Neuropathy, Polyneuropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo-Ranolazine

Arm Type

Experimental

Arm Description

Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6, then ranolazine during Weeks 7 to 12.

Arm Title

Ranolazine-Placebo

Arm Type

Experimental

Arm Description

Participants were randomized to receive ranolazine during Weeks 1 to 6, then placebo to match ranolazine during Weeks 7 to 12.

Intervention Type

Drug

Intervention Name(s)

Ranolazine

Other Intervention Name(s)

Ranexa

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).

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo to match ranolazine administered twice a day for 6 weeks

Primary Outcome Measure Information:

Title

Reduction in Neuropathic Pain

Description

Reduction in patient-reported neuropathic pain (by 2 numeric levels as measured by the Numeric Pain Scale)

Time Frame

Baseline to Week 6

Secondary Outcome Measure Information:

Title

Assess Participant Quality of Life Utilizing the Short Form 36 Health Survey (SF-36v2) Questionnaire

Description

The participant quality of life assessed utilizing the SF-36v2 questionnaire

Time Frame

Baseline to Week 6

Title

Response to Thermal and Mechanical Stimuli

Description

The participant response to thermal and mechanical stimuli as measured by the Hargreaves and Von Frey tests

Time Frame

Baseline to Week 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Craig Walker, MD

Organizational Affiliation

Cardiovascular Institute of the South Clinical Research Corporation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cardiovascular Institute of the South Clinical Research Corporation

City

Houma

State/Province

Louisiana

ZIP/Postal Code

70360

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.neuropathy.org/

Description

The Neuropathy Association, a public, non-profit organization providing information and support for patients with neuropathy

Learn more about this trial

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

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