Gabapentin Versus Transdermal Fentanyl Matrix for Chronic Neuropathic Pain

Gabapentin Versus Transdermal Fentanyl Matrix (TDF) for Chronic Neuropathic Pain (of Radicular Origin): A Multicenter Randomized, Parallel Group, Rater Blinded, Non-inferiority Trial

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.

Study Overview

• Status: Completed
• Conditions: Neuropathic Pain; Spinal Stenosis
• Intervention / Treatment: Drug: transdermal fentanyl matrix, gabapentin

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 156-707
    • Seoul National University, College of Medicine, Department of Orthopedic Surgery, SMG-SNU Boramae Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transdermal fentany matrix; 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.	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.
Active Comparator: gabapentin; Gabapentin is the first-line medication in neuropathic pain. So, gabapentin is active comparator in this study and transdermal fentanyl matrix is experimental.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Visit1 (Day 1), Visit 2 (Day 22-36), Vist3 (Day 50-64)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Visit 1(Day 1), Visit 2(Day 22-36), Visit 3 (Day 50-64)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Asan Medical Center; Chonnam National University Hospital; Seoul National University Bundang Hospital; Chung-Ang University Hosptial, Chung-Ang University College of Medicine; Inje University; Dankook University
• Investigators: Principal Investigator: Jae Hyup Lee, MD, PhD, Seoul National University, College of Medicine, Department of Orthopedic Surgery, SMG-SNU Boramae Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: May 19, 2010
• First Submitted That Met QC Criteria: May 19, 2010
• First Posted (Estimate): May 20, 2010

Study Record Updates

• Last Update Posted (Estimate): July 26, 2016
• Last Update Submitted That Met QC Criteria: July 23, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: neuropathic pain; multicenter; gabapentin; non-inferiority trial; transdermal fentanyl matrix
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Spinal Diseases; Bone Diseases; Neuralgia; Spinal Stenosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Adjuvants, Anesthesia; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Fentanyl; Gabapentin
• Other Study ID Numbers: Neuropathic pain 2010