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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00832572
• Other study ID #: CVT 3042
• Status: Terminated
• Phase: Phase 4
• First received: January 28, 2009
• Last updated: May 23, 2014
• Start date: January 2009
• Est. completion date: June 2009

Study information

• Verified date: May 2014
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Nervous System Diseases
• Pain
• Peripheral Nervous System Diseases
• Polyneuropathies
• Polyneuropathy

Intervention

Drug:
• Ranolazine
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
Placebo to match ranolazine administered twice a day for 6 weeks

Locations

Country	Name	City	State
United States	Cardiovascular Institute of the South Clinical Research Corporation	Houma	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No

External Links

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