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

This study has been terminated.
(Lack of enrollment)
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00832572
First received: January 28, 2009
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Pain
Peripheral Nervous System Diseases
Polyneuropathy
Drug: Ranolazine
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Cross-over Study of Ranolazine in Patients With Coronary Artery Disease for the Treatment of Painful Polyneuropathy

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Reduction in Neuropathic Pain [ Time Frame: Baseline to Week 6 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to Week 6 ] [ Designated as safety issue: No ]
    The participant quality of life assessed utilizing the SF-36v2 questionnaire

  • Response to Thermal and Mechanical Stimuli [ Time Frame: Baseline to Week 6 ] [ Designated as safety issue: No ]
    The participant response to thermal and mechanical stimuli as measured by the Hargreaves and Von Frey tests


Enrollment: 5
Study Start Date: January 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Placebo-Ranolazine
Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6, then ranolazine during Weeks 7 to 12.
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).
Other Name: Ranexa
Drug: Placebo
Placebo to match ranolazine administered twice a day for 6 weeks
Experimental: Ranolazine-Placebo
Participants were randomized to receive ranolazine during Weeks 1 to 6, then placebo to match ranolazine during Weeks 7 to 12.
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).
Other Name: Ranexa
Drug: Placebo
Placebo to match ranolazine administered twice a day for 6 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00832572

Locations
United States, Louisiana
Cardiovascular Institute of the South Clinical Research Corporation
Houma, Louisiana, United States, 70360
Sponsors and Collaborators
Gilead Sciences
Investigators
Principal Investigator: Craig Walker, MD Cardiovascular Institute of the South Clinical Research Corporation
  More Information

Additional Information:
No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00832572     History of Changes
Other Study ID Numbers: CVT 3042
Study First Received: January 28, 2009
Results First Received: May 28, 2013
Last Updated: May 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Gilead Sciences:
Coronary Artery Disease
Pain
Peripheral Neuropathy
Polyneuropathy

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Nervous System Diseases
Peripheral Nervous System Diseases
Polyneuropathies
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Neuromuscular Diseases
Ranolazine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014