Clinical trial NCT01127100: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuropathic Pain
Spinal Stenosis
Keywords: neuropathic pain
gabapentin
transdermal fentanyl matrix
multicenter
non-inferiority trial
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
name: Asan Medical Center
name: Inje University
name: Chonnam National University Hospital
name: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Dankook University
First posted: 2010-05-20
Enrollment: 108
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pain intensity difference between gabapentin used group and transdermal fentanyl matrix used group
timeFrame: Visit1 (Day 1), Visit 2 (Day 22-36), Vist3 (Day 50-64)
Secondary outcomes:
measure: 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
timeFrame: Visit 1(Day 1), Visit 2(Day 22-36), Visit 3 (Day 50-64)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University, College of Medicine, Department of Orthopedic Surgery, SMG-SNU Boramae Medical Center
Study officials:
affiliation: Seoul National University, College of Medicine, Department of Orthopedic Surgery, SMG-SNU Boramae Medical Center
name: Jae Hyup Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.