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Gabapentin in traumatic nerve injury pain: A randomized, double-blind, placebo-controlled, cross-over, mufti-center study

Gordh, Torsten E.; Stubhaug, Audun; Jensen, Troels S.; Arner, Stafan; Biber, Bjorn; Boivie, Jorgen; Mannheimer, Clas; Kalliomaki, Jarkko LU and Kalso, Eija (2008) In Pain 138(2). p.255-266
Abstract
A double-blind, randomized, placebo-controlled cross-over multi-center study was conducted to evaluate the efficacy and safety of gabapentin in the treatment of neuropathic pain caused by traumatic or postsurgical peripheral nerve injury, using doses tip to 2400 mg/day. The study comprised a run-in period of two weeks, two treatment periods of five weeks separated by a three weeks' washout period. The primary efficacy variable was the change in the mean pain intensity score from baseline to the last week of treatment. Other variables included pain relief, health related quality of life (SF-36), interference of sleep by pain, Clinician and Patient Global Impression of Change, and adverse effects. Nine centers randomized a total of 120... (More)
A double-blind, randomized, placebo-controlled cross-over multi-center study was conducted to evaluate the efficacy and safety of gabapentin in the treatment of neuropathic pain caused by traumatic or postsurgical peripheral nerve injury, using doses tip to 2400 mg/day. The study comprised a run-in period of two weeks, two treatment periods of five weeks separated by a three weeks' washout period. The primary efficacy variable was the change in the mean pain intensity score from baseline to the last week of treatment. Other variables included pain relief, health related quality of life (SF-36), interference of sleep by pain, Clinician and Patient Global Impression of Change, and adverse effects. Nine centers randomized a total of 120 patients, 22 of whom withdrew. There was no statistically significant difference between the treatments for the primary outcome efficacy variable. However, gabapentin provided significantly better pain relief (p = 0.015) compared with placebo. More patients had at least a 30% pain reduction with gabapentin compared with placebo (p = 0.040) and pain interfered significantly less with sleep during gabapentin treatment compared with placebo (p = 0.0016). Both the Patient (p = 0.023) and Clinician (p = 0.037) Global Impression of Change indicated a better response with gabapentin compared with placebo. Gabapentin was well tolerated. The most common adverse effects were dizziness and tiredness. (C) 2007 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
controlled cross-over trial, randomized, gabapentin, neuropathic pain, traumatic nerve injury
in
Pain
volume
138
issue
2
pages
255 - 266
publisher
Elsevier
external identifiers
  • wos:000259772900004
  • scopus:43549114363
ISSN
1872-6623
DOI
10.1016/j.pain.2007.12.011
language
English
LU publication?
yes
id
fe283727-c78d-4562-a650-41a662e3fa7e (old id 1286584)
date added to LUP
2009-01-29 16:28:57
date last changed
2017-08-06 03:51:30
@article{fe283727-c78d-4562-a650-41a662e3fa7e,
  abstract     = {A double-blind, randomized, placebo-controlled cross-over multi-center study was conducted to evaluate the efficacy and safety of gabapentin in the treatment of neuropathic pain caused by traumatic or postsurgical peripheral nerve injury, using doses tip to 2400 mg/day. The study comprised a run-in period of two weeks, two treatment periods of five weeks separated by a three weeks' washout period. The primary efficacy variable was the change in the mean pain intensity score from baseline to the last week of treatment. Other variables included pain relief, health related quality of life (SF-36), interference of sleep by pain, Clinician and Patient Global Impression of Change, and adverse effects. Nine centers randomized a total of 120 patients, 22 of whom withdrew. There was no statistically significant difference between the treatments for the primary outcome efficacy variable. However, gabapentin provided significantly better pain relief (p = 0.015) compared with placebo. More patients had at least a 30% pain reduction with gabapentin compared with placebo (p = 0.040) and pain interfered significantly less with sleep during gabapentin treatment compared with placebo (p = 0.0016). Both the Patient (p = 0.023) and Clinician (p = 0.037) Global Impression of Change indicated a better response with gabapentin compared with placebo. Gabapentin was well tolerated. The most common adverse effects were dizziness and tiredness. (C) 2007 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.},
  author       = {Gordh, Torsten E. and Stubhaug, Audun and Jensen, Troels S. and Arner, Stafan and Biber, Bjorn and Boivie, Jorgen and Mannheimer, Clas and Kalliomaki, Jarkko and Kalso, Eija},
  issn         = {1872-6623},
  keyword      = {controlled cross-over trial,randomized,gabapentin,neuropathic pain,traumatic nerve injury},
  language     = {eng},
  number       = {2},
  pages        = {255--266},
  publisher    = {Elsevier},
  series       = {Pain},
  title        = {Gabapentin in traumatic nerve injury pain: A randomized, double-blind, placebo-controlled, cross-over, mufti-center study},
  url          = {http://dx.doi.org/10.1016/j.pain.2007.12.011},
  volume       = {138},
  year         = {2008},
}