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Ranolazine for Diabetic Peripheral Neuropathic Pain (DPNP)

NCT02156336 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2017-02-10

No results posted yet for this study

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

Interventions

DRUG

Ranolazine

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • Horizons International Peripheral Group

    lead OTHER

Principal Investigators

  • Craig M Walker, MD FACC · Cardiovascular Institute of the South

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2017-02-08
Completion
2017-02-08

Countries

  • United States

Study Locations

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Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02156336 on ClinicalTrials.gov