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Gabapentin Versus Transdermal Fentanyl Matrix for Chronic Neuropathic Pain

Primary Purpose

Neuropathic Pain, Spinal Stenosis

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
transdermal fentanyl matrix, gabapentin
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain focused on measuring neuropathic pain, gabapentin, transdermal fentanyl matrix, multicenter, non-inferiority trial

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients are 20 years of age or older
  • patients had chronic pain for more than 3 months and average pain score for last 3 days is not less than 4 (NRS)
  • neuropathic pain caused by the spinal stenosis (radiating pain, motor or sensory change
  • positive MRI finding or radiculopathy was confirmed by the EMG/NCS or not less than 12 points in the S-LANSS score assessment
  • patients who can make out the questionnaire
  • patients have agreed with the informed consent

Exclusion Criteria:

  • patients who have experience with gabapentin, pregabalin, fentanyl matrix, long-acting strong opioid (CR oxycodone, SR morphine)
  • patients who have other causes of neuropathy such as hypothyroidism, Vit B12 deficiency, connective tissue disease, etc.
  • patients who have other disease which causes more pain compared with neuropathic pain
  • patients with a history of drug or alcohol abuse
  • patients who are pregnant or have the possibility of pregnancy
  • patients who are unable to use a transdermal system due to skin disease
  • patients with a serious mental disease
  • patients with a history of hypersensitivity to opioid analgesics
  • patients with a chronic pulmonary disease or respiratory depression
  • patients combined with industrial accidents or traffic accidents
  • at investigator's discretion, any condition where a subject cannot take part in the clinical study on the ground of warning, cautions, and prohibition in study investigator's brochure

Sites / Locations

  • Seoul National University, College of Medicine, Department of Orthopedic Surgery, SMG-SNU Boramae Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Transdermal fentany matrix

gabapentin

Arm Description

Transdermal fentanyl matrix is second-line medication on the neuropathic pain but gabapentin is the first-line medication. So, transdermal fentanyl matrix is experimental arm and gabapentin is active comparator arm.

Gabapentin is the first-line medication in neuropathic pain. So, gabapentin is active comparator in this study and transdermal fentanyl matrix is experimental.

Outcomes

Primary Outcome Measures

Pain intensity difference between gabapentin used group and transdermal fentanyl matrix used group
Post-treatment pain intensity scores will be used to determine the percentage of pain intensity difference between gabapentin used group and transdermal fentanyl matrix used group.

Secondary Outcome Measures

Differences of Oswestry Disability Index score, SF-36, BDI score, investigator and patients global assessment between gabapentin used group and transdermal fentanyl matrix used group
Post-treatment secondary efficacy assessments will be used to determine the percentage of difference and secondary efficacy assessments included the following. 1. Korean Oswestry Disability Index score, Korean-Short-Form 36, Beck Depression Index score, investigator and patients global assessment.

Full Information

First Posted
May 19, 2010
Last Updated
July 23, 2016
Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital, Asan Medical Center, Inje University, Chonnam National University Hospital, Chung-Ang University Hosptial, Chung-Ang University College of Medicine, Dankook University
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1. Study Identification

Unique Protocol Identification Number
NCT01127100
Brief Title
Gabapentin Versus Transdermal Fentanyl Matrix for Chronic Neuropathic Pain
Official Title
Gabapentin Versus Transdermal Fentanyl Matrix (TDF) for Chronic Neuropathic Pain (of Radicular Origin): A Multicenter Randomized, Parallel Group, Rater Blinded, Non-inferiority Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital, Asan Medical Center, Inje University, Chonnam National University Hospital, Chung-Ang University Hosptial, Chung-Ang University College of Medicine, Dankook University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain, Spinal Stenosis
Keywords
neuropathic pain, gabapentin, transdermal fentanyl matrix, multicenter, non-inferiority trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transdermal fentany matrix
Arm Type
Experimental
Arm Description
Transdermal fentanyl matrix is second-line medication on the neuropathic pain but gabapentin is the first-line medication. So, transdermal fentanyl matrix is experimental arm and gabapentin is active comparator arm.
Arm Title
gabapentin
Arm Type
Active Comparator
Arm Description
Gabapentin is the first-line medication in neuropathic pain. So, gabapentin is active comparator in this study and transdermal fentanyl matrix is experimental.
Intervention Type
Drug
Intervention Name(s)
transdermal fentanyl matrix, gabapentin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain intensity difference between gabapentin used group and transdermal fentanyl matrix used group
Description
Post-treatment pain intensity scores will be used to determine the percentage of pain intensity difference between gabapentin used group and transdermal fentanyl matrix used group.
Time Frame
Visit1 (Day 1), Visit 2 (Day 22-36), Vist3 (Day 50-64)
Secondary Outcome Measure Information:
Title
Differences of Oswestry Disability Index score, SF-36, BDI score, investigator and patients global assessment between gabapentin used group and transdermal fentanyl matrix used group
Description
Post-treatment secondary efficacy assessments will be used to determine the percentage of difference and secondary efficacy assessments included the following. 1. Korean Oswestry Disability Index score, Korean-Short-Form 36, Beck Depression Index score, investigator and patients global assessment.
Time Frame
Visit 1(Day 1), Visit 2(Day 22-36), Visit 3 (Day 50-64)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients are 20 years of age or older patients had chronic pain for more than 3 months and average pain score for last 3 days is not less than 4 (NRS) neuropathic pain caused by the spinal stenosis (radiating pain, motor or sensory change positive MRI finding or radiculopathy was confirmed by the EMG/NCS or not less than 12 points in the S-LANSS score assessment patients who can make out the questionnaire patients have agreed with the informed consent Exclusion Criteria: patients who have experience with gabapentin, pregabalin, fentanyl matrix, long-acting strong opioid (CR oxycodone, SR morphine) patients who have other causes of neuropathy such as hypothyroidism, Vit B12 deficiency, connective tissue disease, etc. patients who have other disease which causes more pain compared with neuropathic pain patients with a history of drug or alcohol abuse patients who are pregnant or have the possibility of pregnancy patients who are unable to use a transdermal system due to skin disease patients with a serious mental disease patients with a history of hypersensitivity to opioid analgesics patients with a chronic pulmonary disease or respiratory depression patients combined with industrial accidents or traffic accidents at investigator's discretion, any condition where a subject cannot take part in the clinical study on the ground of warning, cautions, and prohibition in study investigator's brochure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae Hyup Lee, MD, PhD
Organizational Affiliation
Seoul National University, College of Medicine, Department of Orthopedic Surgery, SMG-SNU Boramae Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University, College of Medicine, Department of Orthopedic Surgery, SMG-SNU Boramae Medical Center
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
30863474
Citation
Hwang CJ, Lee JH, Kim JH, Min SH, Park KW, Seo HY, Song KS. Gabapentin versus Transdermal Fentanyl Matrix for the Alleviation of Chronic Neuropathic Pain of Radicular Origin: A Randomized Blind Multicentered Parallel-Group Noninferiority Trial. Pain Res Manag. 2019 Feb 4;2019:4905013. doi: 10.1155/2019/4905013. eCollection 2019.
Results Reference
derived

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Gabapentin Versus Transdermal Fentanyl Matrix for Chronic Neuropathic Pain

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