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Gabapentin Versus Transdermal Fentanyl Matrix for Chronic Neuropathic Pain

NCT01127100 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2016-07-26

No results posted yet for this study

Summary

Gabapentin is a first line medication and fentanyl is second line medication in neuropathic pain. But, there is no head to head study on the efficacy of those medication in neuropathic pain.

The hypothesis of this study is that the efficacy of the transdermal fentanyl matrix is not inferior to the gabapentin in neuropathic pain.

Conditions

  • Neuropathic Pain
  • Spinal Stenosis

Interventions

DRUG

transdermal fentanyl matrix, gabapentin

transdermal fentanyl matrix: during 1st to 6th days, 12ug/h of fentanyl matrix will be applied. During 7th to 28th days, the dosage of fentanyl matrix will be increased until the pain score decrease not more than 2 every 6 days. The maximal dosage is 100ug/h. During 29th to 56th days, the dosage will be maintained. Gabapentin: the 1st day, 300mg hs, the 2nd day, 300mg bid, the 3th to 4th days, 300mg tid, the 5th to 6th days, 300mg-300mg-600mg the 7th to 28 days, the dosage will be increased until the pain score decreased not more than 2 and the maximal dose is 2400mg per day. During 29th to 56th days, the dosage will be maintained.

Sponsors & Collaborators

  • Seoul National University Bundang Hospital

    collaborator OTHER

  • Asan Medical Center

    collaborator OTHER

  • Inje University

    collaborator OTHER

  • Chonnam National University Hospital

    collaborator OTHER

  • Chung-Ang University Hosptial, Chung-Ang University College of Medicine

    collaborator OTHER

  • Dankook University

    collaborator OTHER

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Jae Hyup Lee, MD, PhD · Seoul National University, College of Medicine, Department of Orthopedic Surgery, SMG-SNU Boramae Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • South Korea

Study Locations

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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 NCT01127100 on ClinicalTrials.gov