Gabapentin Versus Transdermal Fentanyl Matrix for Chronic Neuropathic Pain | RxWiki

Gabapentin Versus Transdermal Fentanyl Matrix for Chronic Neuropathic Pain

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Neuropathic Pain Spinal Stenosis
Intervention	Drug: transdermal fentanyl matrix, gabapentin
Phase	Phase 4
Sponsor	Seoul National University Hospital
Responsible Party	Seoul National University Hospital
ClinicalTrials.gov Identifier	NCT01127100
First Received	May 19, 2010
Last Updated	July 19, 2011
Last verified	July 2011

Tracking Information[ + expand ][ + ]

First Received Date	May 19, 2010
Last Updated Date	July 19, 2011
Start Date	May 2010
Estimated Primary Completion Date	January 2012
Current Primary Outcome Measures	Pain intensity difference between gabapentin used group and transdermal fentanyl matrix used group [Time Frame: Visit1 (Day 1), Visit 2 (Day 22-36), Vist3 (Day 50-64)] [Designated as safety issue: No]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.
Current Secondary Outcome Measures	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 [Time Frame: Visit 1(Day 1), Visit 2(Day 22-36), Visit 3 (Day 50-64)] [Designated as safety issue: No]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.

Descriptive Information[ + expand ][ + ]

Brief Title	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
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 Provided
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Condition	Neuropathic Pain Spinal Stenosis
Intervention	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.
Study Arm (s)	Experimental: Transdermal fentany matrix 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. Active Comparator: gabapentin Gabapentin is the first-line medication in neuropathic pain. So, gabapentin is active comparator in this study and transdermal fentanyl matrix is experimental.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Enrolling by invitation
Estimated Enrollment	116
Estimated Completion Date	January 2012
Estimated Primary Completion Date	December 2011
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
Gender	Both
Ages	20 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Korea, Republic of

Administrative Information[ + expand ][ + ]

NCT Number	NCT01127100
Other Study ID Numbers	Neuropathic pain 2010
Has Data Monitoring Committee	No
Information Provided By	Seoul National University Hospital
Study Sponsor	Seoul National University Hospital
Collaborators	Seoul National University Bundang Hospital Masan Samsung Hospital, South Korea Asan Medical Center Inje University Chonnam National University Hospital Chung-Ang University
Investigators	Principal Investigator: Jae Hyup Lee, MD, PhD Seoul National University, College of Medicine, Department of Orthopedic Surgery, SMG-SNU Boramae Medical Center
Verification Date	July 2011

Locations[ + expand ][ + ]