Coronary Artery Disease, Pain, Peripheral Nervous System Diseases, Polyneuropathy
Conditions
Keywords
Coronary Artery Disease, Pain, Peripheral Neuropathy, Polyneuropathy
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.
Interventions
DRUGRanolazine
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).
DRUGPlacebo
Placebo to match ranolazine administered twice a day for 6 weeks
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Neuropathic Pain | Baseline to Week 6 | Reduction in patient-reported neuropathic pain (by 2 numeric levels as measured by the Numeric Pain Scale) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess Participant Quality of Life Utilizing the Short Form 36 Health Survey (SF-36v2) Questionnaire | Baseline to Week 6 | The participant quality of life assessed utilizing the SF-36v2 questionnaire |
| Response to Thermal and Mechanical Stimuli | Baseline to Week 6 | The participant response to thermal and mechanical stimuli as measured by the Hargreaves and Von Frey tests |
Countries
United States
Participant flow
Recruitment details
Five participants were enrolled and treated.
Participants by arm
| Arm | Count |
|---|---|
| Placebo/Ranolazine Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2). | 3 |
| Ranolazine/Placebo Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2). | 2 |
| Total | 5 |
Baseline characteristics
| Characteristic | Placebo/Ranolazine | Ranolazine/Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 0 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 3 | 0 / 3 | 0 / 2 | 1 / 2 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 | 0 / 2 | 0 / 2 |
Outcome results
Primary
Reduction in Neuropathic Pain
Reduction in patient-reported neuropathic pain (by 2 numeric levels as measured by the Numeric Pain Scale)
Time frame: Baseline to Week 6
Population: Study was stopped and no analysis was performed on the primary outcome measure.
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
Time frame: Baseline to Week 6
Population: Study was stopped and no analyses were performed on the secondary outcome measures.
Secondary
Response to Thermal and Mechanical Stimuli
The participant response to thermal and mechanical stimuli as measured by the Hargreaves and Von Frey tests
Time frame: Baseline to Week 6
Population: Study was stopped and no analyses were performed on the secondary outcome measures.