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The Effect of Pregabalin on Pain Related to Walking in Patients With Diabetic Peripheral Neuropathy

NCT02927951 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2016-10-07

No results posted yet for this study

Summary

The hypothesis of this study is that pregabalin, 150 mg bid, will reduce general daytime pain in patients diagnosed with diabetic peripheral neuropathy and that it will also reduce the level of pain associated with walking. Consequently, it is hypothesized that the reduction in pain will result in an increase in the amount of walking they do during the day, improvements in their gait, balance, risk of falls and sleep patterns.

Conditions

  • Diabetic Peripheral Neuropathy
  • Nerve Pain

Interventions

DRUG

Pregabalin

150mg bid

DRUG

Placebo

150mg bid

Sponsors & Collaborators

  • Old Dominion University

    collaborator OTHER

  • Eastern Virginia Medical School

    lead OTHER

Principal Investigators

  • Aaron I Vinik, PhD, MD · Eastern Virginia Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02927951 on ClinicalTrials.gov