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Gabapentin Versus Transdermal Fentanyl Matrix for Chronic Neuropathic Pain

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ClinicalTrials.gov Identifier: NCT01127100
Recruitment Status : Completed
First Posted : May 20, 2010
Last Update Posted : July 26, 2016
Sponsor:
Collaborators:
Seoul National University Bundang Hospital
Asan Medical Center
Inje University
Chonnam National University Hospital
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Dankook University
Information provided by (Responsible Party):
Jae Hyup Lee, Seoul National University Hospital

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.


Condition or disease Intervention/treatment Phase
Neuropathic Pain Spinal Stenosis Drug: transdermal fentanyl matrix, gabapentin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.


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.
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.





Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01127100


Locations
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Korea, Republic of
Seoul National University, College of Medicine, Department of Orthopedic Surgery, SMG-SNU Boramae Medical Center
Seoul, Korea, Republic of, 156-707
Sponsors and Collaborators
Seoul National University Hospital
Seoul National University Bundang Hospital
Asan Medical Center
Inje University
Chonnam National University Hospital
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Dankook University
Investigators
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Principal Investigator: Jae Hyup Lee, MD, PhD Seoul National University, College of Medicine, Department of Orthopedic Surgery, SMG-SNU Boramae Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jae Hyup Lee, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01127100     History of Changes
Other Study ID Numbers: Neuropathic pain 2010
First Posted: May 20, 2010    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016
Keywords provided by Jae Hyup Lee, Seoul National University Hospital:
neuropathic pain
gabapentin
transdermal fentanyl matrix
multicenter
non-inferiority trial
Additional relevant MeSH terms:
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Spinal Stenosis
Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Fentanyl
Gabapentin
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents