Ranolazine for Diabetic Peripheral Neuropathic Pain (DPNP)

NCT02156336 | Terminated Phase 4

• 1 other identifier: HIPG-CLIN-2014-01
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetic Peripheral Neuropathic Pain

Keywords

Diabetic Peripheral Neuropathic Pain; Ranexa; Ranolazine; Neurology

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks (42 Days)

Secondary Outcomes (7)

• Change in Quality of Life Assessment as measured by SF-36 v2

  Randomization (Day 0) and Day 42

• 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

Study Arms (2)

PLACEBO

PLACEBO COMPARATOR

* 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)

Drug: Placebo

RANOLAZINE

ACTIVE COMPARATOR

* 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)

Drug: Ranolazine

Interventions

Ranolazine DRUG

Oral administration, BID; for a maximum of 51 days.

Also known as: Ranexa

RANOLAZINE

Placebo DRUG

Oral administration, BID; for a maximum of 51 days.

Also known as: Sugar Pill

PLACEBO

Eligibility Criteria

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

You may qualify if:

• 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:
• 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,
• 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:
• Stable regimen of hormonal contraception
• Intra-uterine device
• Condoms with spermicide
• Diaphragm with spermicide

You may not qualify if:

• 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);
• Renal impairment as defined by a calculated serum creatinine clearance of \< 30ml/min;
• Lower back disorders where symptoms present similarly to DPNP;
• Family history of long QT syndrome;
• Congenital long QT syndrome;
• Subjects taking tricyclic antidepressants;

Sponsors & Collaborators

• Horizons International Peripheral Group: lead
• Gilead Sciences: collaborator

Study Sites (3)

Cardiology Associates

Fairhope, Alabama, 36532, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70361, United States

Location

Cardiovascular Institute of the South

Lafayette, Louisiana, 70503, United States

Location

Related Publications (1)

• 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.

  PMID: 19773645 BACKGROUND

MeSH Terms

Interventions

Ranolazine; Sugars

Intervention Hierarchy (Ancestors)

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

Study Officials

• Craig M Walker, MD FACC

  Cardiovascular Institute of the South

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: June 5, 2014
• Study Start: May 1, 2014
• Primary Completion: February 8, 2017
• Study Completion: February 8, 2017
• Last Updated: February 10, 2017

Record last verified: 2017-02

Locations

US (3)