Gabapentin Versus Transdermal Fentanyl Matrix for Chronic Neuropathic Pain

NCT ID: NCT01127100

Last Updated: 2016-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-11-30

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.

Conditions

Neuropathic Pain; Spinal Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

transdermal fentanyl matrix, gabapentin

Intervention Type: 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.

gabapentin

Gabapentin is the first-line medication in neuropathic pain. So, gabapentin is active comparator in this study and transdermal fentanyl matrix is experimental.

Group Type: ACTIVE_COMPARATOR

transdermal fentanyl matrix, gabapentin

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Bundang Hospital

OTHER

Sponsor Role: collaborator

Asan Medical Center

OTHER

Sponsor Role: collaborator

Inje University

OTHER

Sponsor Role: collaborator

Chonnam National University Hospital

OTHER

Sponsor Role: collaborator

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

OTHER

Sponsor Role: collaborator

Dankook University

OTHER

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jae Hyup Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jae Hyup Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University, College of Medicine, Department of Orthopedic Surgery, SMG-SNU Boramae Medical Center

Locations

Seoul National University, College of Medicine, Department of Orthopedic Surgery, SMG-SNU Boramae Medical Center

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 30863474 (View on PubMed)

Other Identifiers

Neuropathic pain 2010

Identifier Type: -

Identifier Source: org_study_id