Trial | NCT01127100  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    108
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 Started
May 31
2010
Primary Completion
Nov 30
2011
Study Completion
Nov 30
2011
Last Update
Jul 26
2016
Estimate

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.

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.

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
No Results Posted