A Double-Blind, Placebo-Controlled, Randomized, Parallel Assignment, U.S. Study of Ranolazine for the Treatment of Patients With Diabetic Peripheral Neuropathic Pain (DPNP)

Horizons International Peripheral Group2 sites in 1 country4 target enrollmentMay 2014

ConditionsDiabetic Peripheral Neuropathic Pain

InterventionsPlacebo Ranolazine

Overview

Phase: Phase 4
Intervention: Placebo
Conditions: Diabetic Peripheral Neuropathic Pain
Sponsor: Horizons International Peripheral Group
Enrollment: 4
Locations: 2
Primary Endpoint: 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.
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

May 2014

End Date

February 8, 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Horizons International Peripheral Group

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•A minimum of 18 years of age;
•Provided signed Informed Consent Form and Health Insurance Portability and Accountability Act (HIPAA) authorization for this study approved by the Institutional Review Board;
•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;
•Diabetic on a stable insulin regimen or oral medication regimen as determined by the investigator \[It is recommended Hba1c \< 9.5%, making a note that lab normal values may vary among sites.\];
•Clinical Exam Results:
•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.
•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.
•Willing and able to comply with the requirements of the protocol and follow directions from the clinic and research staff;
•For female patients only:
•Be post-menopausal (no menses for at least 2 years) or sterilized,

Exclusion Criteria

•History of allergy or intolerance to ranolazine;
•Any condition or concomitant medication that would preclude the safe use of ranolazine as outlined in the prescribing information sheet;
•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 participation in another experimental or investigational drug or device trial;
•Pregnant or breast feeding;
•Cirrhosis of the liver;
•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;
•Taking a moderate or strong CYP3A inhibitor (e.g. diltiazem, verapamil, ketoconazole, itraconazole, clarithromycin, erythromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir);
•Taking inducers of Cytochrome P450, family 3, subfamily A (CYP3A) (e.g. rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort);

Arms & Interventions

PLACEBO

* 500 mg PLACEBO PO 2 times a day for 1 week (Week 1) * 1000 mg PLACEBO PO 2 times a day for 5 weeks (Weeks 2,3,4,5,6)

Intervention: Placebo

RANOLAZINE

* 500 mg RANOLAZINE PO 2 times a day for 1 week (Week 1) * 1000 mg RANOLAZINE PO 2 times a day for 5 weeks (Weeks 2,3,4,5,6)

Intervention: Ranolazine

Outcomes

Primary Outcomes

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.

Time Frame: 6 weeks (42 Days)

Secondary Outcomes

Change in pain assessment measured by the Visual Analog Scale(Randomization (Day 0), Day 14, Day 28, Day 42, and Day 56)
Change in pain assessment measured by Short-Form McGill Pain Questionnaire(Randomization (Day 0) and Day 42)
Change in pain of patients with arterial ischemia measured by Short-Form McGill Pain Questionnaire(Randomization (Day 0), Day 14, Day 28, Day 42, and Day 56)
Additional pain medication(Randomization (Day 0), Day 14, Day 28, Day 42, and Day 56)
Occurrence of Adverse Events after randomization(56 Days)
Change in Quality of Life Assessment as measured by SF-36 v2(Randomization (Day 0) and Day 42)
Occurrence of Serious Adverse Events after randomization(56 Days)