Ranolazine for Diabetic Peripheral Neuropathic Pain (DPNP)
Information source: Horizons International Peripheral Group
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Peripheral Neuropathic Pain
Intervention: Ranolazine (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Horizons International Peripheral Group Official(s) and/or principal investigator(s): Craig M Walker, MD FACC, Principal Investigator, Affiliation: Cardiovascular Institute of the South
Overall contact: Chris A Schultz, BS, Phone: 971-506-7552, Email: CSchultz@ecr-inc.com
Summary
The purpose of this trial is to determine if patients suffering from diabetic peripheral
neuropathic pain treated with ranolazine will have a greater reduction in pain compared to
placebo.
Hypothesis: From the prior clinical observations, and analgesic efficacy in the preclinical
animal model of neuropathic pain, the investigators hypothesize that subjects randomized to
ranolazine will show a greater reduction in diabetic neuropathic pain compared to placebo.
Clinical Details
Official title: A Double-Blind, Placebo-Controlled, Randomized, Parallel Assignment, U.S. Study of Ranolazine for the Treatment of Patients With Diabetic Peripheral Neuropathic Pain (DPNP)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Fifty percent or greater reduction in the mean Numeric Rating Scale (11-point NRS 0-10) recorded in the subjects' diaries from ranolazine compared to placebo.
Secondary outcome: Change in Quality of Life Assessment as measured by SF-36 v2Change in pain assessment measured by the Visual Analog Scale Change in pain assessment measured by Short-Form McGill Pain Questionnaire Change in pain of patients with arterial ischemia measured by Short-Form McGill Pain Questionnaire Additional pain medication Occurrence of Adverse Events after randomization Occurrence of Serious Adverse Events after randomization
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. A minimum of 18 years of age;
2. Provided signed Informed Consent Form and Health Insurance Portability and
Accountability Act (HIPAA) authorization for this study approved by the Institutional
Review Board;
3. Patients must have diabetic peripheral neuropathic pain rated at an average level of
six (6) or above as documented in daily diary prior to baseline visit and noted at
Baseline Visit;
4. Diabetic on a stable insulin regimen or oral medication regimen as determined by the
investigator [It is recommended Hba1c < 9. 5%, making a note that lab normal values
may vary among sites.];
5. Clinical Exam Results:
1. 5. 07 Semmes-Weinstein Monofilament Test Subject does not sense monofilament or
evokes an abnormal response in a minimum of two (2) out of five (5) test
locations on the plantar surface of the foot.
2. Pin Prick Test Subject experiences allodynia, hyperalgesia, or sensory loss in
two (2) out of five (5) test locations in the plantar surface - four (4) and
dorsum - one (1) of the foot.
6. Willing and able to comply with the requirements of the protocol and follow
directions from the clinic and research staff;
7. For female patients only:
- Be post-menopausal (no menses for at least 2 years) or sterilized,
- If subject of childbearing potential, not breastfeeding, has a negative
pregnancy test at Baseline (pre-randomization, Day 0), has no intention of
becoming pregnant during the course of the study, and is using one or more of
the following contraceptive measures:
1. Stable regimen of hormonal contraception
2. Intra-uterine device
3. Condoms with spermicide
4. Diaphragm with spermicide
Exclusion Criteria:
1. History of allergy or intolerance to ranolazine;
2. Any condition or concomitant medication that would preclude the safe use of
ranolazine as outlined in the prescribing information sheet;
3. 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;
4. In the judgment of the investigator, clinically-significant abnormal physical
findings during screening (excluding the patient's peripheral neuropathy condition);
5. Use participation in another experimental or investigational drug or device trial;
6. Pregnant or breast feeding;
7. Cirrhosis of the liver;
8. Psychological or addictive disorders (not limited to, but including for example, drug
and/or alcohol dependency) that may preclude patient consent or compliance, or that
may confound study interpretation;
9. Taking a moderate or strong CYP3A inhibitor (e. g. diltiazem, verapamil, ketoconazole,
itraconazole, clarithromycin, erythromycin, nefazodone, nelfinavir, ritonavir,
indinavir, and saquinavir);
10. Taking inducers of Cytochrome P450, family 3, subfamily A (CYP3A) (e. g. rifampin,
rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's
wort);
11. Renal impairment as defined by a calculated serum creatinine clearance of < 30ml/min;
12. Lower back disorders where symptoms present similarly to DPNP;
13. Family history of long QT syndrome;
14. Congenital long QT syndrome;
15. Subjects taking tricyclic antidepressants;
16. Subjects taking anti-psychotic drugs;
17. Patient is taking > 850mg metformin BID;
18. Any subjects currently taking pregabalin;
19. Any subjects currently taking gabapentin;
20. Any subject currently taking Metanx®;
21. Any subjects currently taking continuous long-term narcotics;
22. Grapefruit and grapefruit containing products;
23. Use of P-gp inhibitors - cyclosporine.
Locations and Contacts
Chris A Schultz, BS, Phone: 971-506-7552, Email: CSchultz@ecr-inc.com
Cardiology Associates, Fairhope, Alabama 36532, United States; Recruiting Mary Austin, RN, Phone: 251-990-1936, Email: MAustin@cardassoc.com Frank T Bunch, MD FACC, Principal Investigator
Cardiovascular Institute of the South, Houma, Louisiana 70361, United States; Recruiting Deanna K Benoit, LPN, Phone: 985-873-5613, Email: Deanna.Benoit@cardio.com Craig M Walker, MD FACC, Principal Investigator
Cardiovascular Institute of the South, Lafayette, Louisiana 70503, United States; Recruiting Shontel Cleveland, LPN, Phone: 337-289-8429, Email: Shontel.Cleveland@cardio.com Nick Cavros, MD FACC, Principal Investigator
Additional Information
Related publications: Gould HJ 3rd, Garrett C, Donahue RR, Paul D, Diamond I, Taylor BK. Ranolazine attenuates behavioral signs of neuropathic pain. Behav Pharmacol. 2009 Dec;20(8):755-8. doi: 10.1097/FBP.0b013e3283323c90.
Starting date: May 2014
Last updated: August 18, 2015
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