Clinical trial NCT00832572: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Coronary Artery Disease
Pain
Peripheral Nervous System Diseases
Polyneuropathy
Keywords: Coronary Artery Disease
Pain
Peripheral Neuropathy
Polyneuropathy
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2009-01-30
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Reduction in Neuropathic Pain
timeFrame: Baseline to Week 6
Secondary outcomes:
measure: Assess Participant Quality of Life Utilizing the Short Form 36 Health Survey (SF-36v2) Questionnaire
timeFrame: Baseline to Week 6
measure: Response to Thermal and Mechanical Stimuli
timeFrame: Baseline to Week 6
Other outcomes:
Locations:
city: Houma
country: United States
facility: Cardiovascular Institute of the South Clinical Research Corporation
state: Louisiana
Study officials:
affiliation: Cardiovascular Institute of the South Clinical Research Corporation
name: Craig Walker, MD
role: PRINCIPAL_INVESTIGATOR
References: