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Gabapentin Versus Transdermal Fentanyl Matrix for Chronic Neuropathic Pain

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neuropathic Pain; Spinal Stenosis

Intervention: transdermal fentanyl matrix, gabapentin (Drug)

Phase: Phase 4

Status: Enrolling by invitation

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Jae Hyup Lee, MD, PhD, Principal Investigator, Affiliation: Seoul National University, College of Medicine, Department of Orthopedic Surgery, SMG-SNU Boramae Medical Center

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.

Clinical 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

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

Primary outcome: Pain intensity difference between gabapentin used group and transdermal fentanyl matrix used group

Secondary outcome: 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

Eligibility

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

Seoul National University, College of Medicine, Department of Orthopedic Surgery, SMG-SNU Boramae Medical Center, Seoul 156-707, Korea, Republic of
Additional Information

Starting date: May 2010
Last updated: May 24, 2015

Page last updated: August 23, 2015

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