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| Name | Class |
|---|---|
| Seoul National University Bundang Hospital | OTHER |
| Asan Medical Center | OTHER |
| Inje University | OTHER |
| Chonnam National University Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transdermal fentany matrix | Experimental | 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 | Active Comparator | Gabapentin is the first-line medication in neuropathic pain. So, gabapentin is active comparator in this study and transdermal fentanyl matrix is experimental. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transdermal fentanyl matrix, gabapentin | Drug | 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. |
| 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jae Hyup Lee, MD, PhD | Seoul National University, College of Medicine, Department of Orthopedic Surgery, SMG-SNU Boramae Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University, College of Medicine, Department of Orthopedic Surgery, SMG-SNU Boramae Medical Center | Seoul | 156-707 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30863474 | Derived | 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. |
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| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| OTHER |
| Chung-Ang University Hospital | OTHER |
| Dankook University | OTHER |
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|
| Visit 1(Day 1), Visit 2(Day 22-36), Visit 3 (Day 50-64) |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |