Gabapentin Versus Transdermal Fentanyl Matrix for Chronic Neuropathic Pain
CompletedPhase 4NCT01127100
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- 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
- Conditions
- Neuropathic Pain
- Spinal Stenosis
- Interventions
- Drug: transdermal fentanyl matrix, gabapentin
- Sponsor
- Seoul National University Hospital
- Collaborators
- Seoul National University Bundang Hospital; Asan Medical Center; Inje University; Chonnam National University Hospital; Chung-Ang University Hospital; Dankook University
- Start date
- 2010-05
- Primary completion
- 2011-11
- Sex
- All
- Age range
- from 20 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- South Korea
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01127100