Gabapentin Versus Transdermal Fentanyl Matrix for Chronic Neuropathic Pain

Neuropathic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01127100
• Other study ID #: Neuropathic pain 2010
• Status: Completed
• Phase: Phase 4
• First received: May 19, 2010
• Last updated: July 23, 2016
• Start date: May 2010
• Est. completion date: November 2011

Study information

• Verified date: July 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University, College of Medicine, Department of Orthopedic Surgery, SMG-SNU Boramae Medical Center	Seoul

Sponsors (7)

Lead Sponsor	Collaborator
Seoul National University Hospital	Asan Medical Center, Chonnam National University Hospital, Chung-Ang University Hosptial, Chung-Ang University College of Medicine, Dankook University, Inje University, Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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.	Visit 1(Day 1), Visit 2(Day 22-36), Visit 3 (Day 50-64)	No