Reporting of Trials of Gabapentin

To the Editor: In the Special Article on outcome reporting in industry-sponsored trials of gabapentin for off-label use, Vedula et al. (Nov. 12 issue) 1 claim to have identified unacceptable reporting practices in certain clinical trials. Our study on gabapentin for pain due to traumatic nerve injur...

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Bibliographic Details
Published inThe New England journal of medicine Vol. 362; no. 17; pp. 1641 - 1642
Main Authors Gordh, Torsten E, Jensen, Troels S, Kalso, Eija
Format Journal Article
LanguageEnglish
Published United States Massachusetts Medical Society 29.04.2010
Subjects
Amines - therapeutic use
Anaesthetics and intensive care
Analgesics - therapeutic use
Anestesiologi och intensivvård
Cyclohexanecarboxylic Acids - therapeutic use
gamma-Aminobutyric Acid - therapeutic use
Humans
Kirurgi
MEDICIN
MEDICINE
Neuralgia - drug therapy
Off-Label Use
R&D
Randomized Controlled Trials as Topic - standards
Research & development
Surgery
Trauma, Nervous System - drug therapy
Treatment Outcome
Variables
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Summary:To the Editor: In the Special Article on outcome reporting in industry-sponsored trials of gabapentin for off-label use, Vedula et al. (Nov. 12 issue) 1 claim to have identified unacceptable reporting practices in certain clinical trials. Our study on gabapentin for pain due to traumatic nerve injury 2 was included as an example of disagreement between the definition of the primary outcome in the protocol and that in the published report. We strongly disagree. New primary outcomes were not introduced in our published report. The primary-outcome variable (i.e., the mean visual-analogue score of the last week of each of the two treatment . . .
Bibliography:SourceType-Other Sources-1
content type line 63
ObjectType-Correspondence-1
ObjectType-Commentary-2
ISSN:0028-4793
1533-4406
1533-4406
DOI:10.1056/NEJMc1000964