Ranolazine for Diabetic Peripheral Neuropathic Pain (DPNP)

NCT ID: NCT02156336

Last Updated: 2017-02-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2017-02-08

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

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)

Group Type: ACTIVE_COMPARATOR

Ranolazine

Intervention Type: DRUG

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

Interventions

Ranolazine

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Ranexa; Sugar Pill

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

Horizons International Peripheral Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Craig M Walker, MD FACC

Role: PRINCIPAL_INVESTIGATOR

Cardiovascular Institute of the South

Locations

Cardiology Associates

Fairhope, Alabama, United States

Cardiovascular Institute of the South

Houma, Louisiana, United States

Cardiovascular Institute of the South

Lafayette, Louisiana, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 19773645 (View on PubMed)

Other Identifiers

HIPG-CLIN-2014-01

Identifier Type: -

Identifier Source: org_study_id