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

NCT00832572 | Terminated Phase 4 Results

• 1 other identifier: CVT 3042
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Coronary Artery Disease; Pain; Peripheral Neuropathy; Polyneuropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  Baseline to Week 6

• Response to Thermal and Mechanical Stimuli

  Baseline to Week 6

Study Arms (2)

Placebo-Ranolazine

EXPERIMENTAL

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

Drug: Ranolazine; Drug: Placebo

Ranolazine-Placebo

EXPERIMENTAL

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

Drug: Ranolazine; Drug: Placebo

Interventions

Ranolazine DRUG

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).

Also known as: Ranexa

Placebo-Ranolazine; Ranolazine-Placebo

Placebo DRUG

Placebo to match ranolazine administered twice a day for 6 weeks

Placebo-Ranolazine; Ranolazine-Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (1)

Cardiovascular Institute of the South Clinical Research Corporation

Houma, Louisiana, 70360, United States

Location

Related Links

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

MeSH Terms

Conditions

Coronary Artery Disease; Pain; Peripheral Nervous System Diseases; Polyneuropathies

Interventions

Ranolazine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The study was stopped after 5 participants were enrolled. No outcome measure analyses were performed. Adverse events were collected and reported to the study center's Institutional Review Board.

Results Point of Contact

• Title: Clinical Trial Disclosures
• Organization: Gilead Sciences, Inc.

ClinicalTrialDisclosures@gilead.com

Study Officials

• Craig Walker, MD

  Cardiovascular Institute of the South Clinical Research Corporation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2009
• First Posted: January 30, 2009
• Study Start: January 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: June 30, 2014
• Results First Posted: June 30, 2014

Record last verified: 2014-05

Locations

US (1)