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NCT Number: NCT01127100

Gabapentin Versus Transdermal Fentanyl Matrix for Chronic Neuropathic Pain

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.

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Key information

Conditions

Neuropathic Pain Bone Diseases Musculoskeletal Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Spinal Diseases Spinal Stenosis

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Seoul, 156-707, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transdermal fentanyl matrix, gabapentin

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.

Primary outcomes

  1. 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)

    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.

Secondary outcomes

  1. 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)

    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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Asan Medical Center
  • Chonnam National University Hospital
  • Chung-Ang University Hospital
  • Dankook University
  • Inje University
  • Seoul National University Bundang Hospital

Registry information

Official study title

Gabapentin Versus Transdermal Fentanyl Matrix (TDF) for Chronic Neuropathic Pain (of Radicular Origin): A Multicenter Randomized, Parallel Group, Rater Blinded, Non-inferiority Trial

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 20, 2010
Registry last updated
Jul 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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