Gabapentin Versus Transdermal Fentanyl Matrix for Chronic Neuropathic Pain

Phase 4

Completed

• Conditions: Neuropathic Pain; Spinal Stenosis
• Interventions: Drug: transdermal fentanyl matrix, gabapentin

• Registration Number: NCT01127100
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-19
• Study First Submitted QC: 2010-05-19
• Study First Posted: 2010-05-20
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-23
• Last Update Posted: 2016-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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)	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

Name	Time	Method
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	Visit 1(Day 1), Visit 2(Day 22-36), Visit 3 (Day 50-64)	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.

Trial Locations

Locations (1)

Seoul National University, College of Medicine, Department of Orthopedic Surgery, SMG-SNU Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of