Department of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington, Bloomington, Indiana, USA
Department of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington, Bloomington, Indiana, USA.
BMJ Open. 2021 Jun 30;11(6):e047785. doi: 10.1136/bmjopen-2020-047785.
Gabapentin (Neurontin) is prescribed widely for conditions for which it has not been approved by regulators, including certain neuropathic pain conditions. There is limited evidence that gabapentin is safe and effective for the treatment of neuropathic pain. Published trial reports, and systematic reviews based on published trial reports, mislead patients and providers because information about gabapentin's harms has been published only partly. We confirmed that trials conducted by the drug developer have been abandoned, and we plan to conduct a restoration with support from the Restoring Invisible and Abandoned Trials Support Centre (https://restoringtrials.org/).
In this study, we will analyse and report the harms that were observed in six trials of gabapentin, which have not been reported publicly (eg, in journal articles). We will use clinical study reports and individual participant data to identify and report the harms observed in each individual trial and to summarise the harms observed across all six trials. We will report all adverse events observed in the included trials by sharing deidentified data and summary tables on the Open Science Framework (https://osf.io/w8puv/). Additionally, we will produce a summary report that describes differences between the randomised groups in each trial and across trials for prespecified harms outcomes.
We will use secondary data. This study was determined to be exempt from Institutional Review Board (IRB) review (protocol #1910607198).
加巴喷丁（Neurontin）被广泛用于未经监管机构批准的疾病，包括某些神经病理性疼痛疾病。有限的证据表明，加巴喷丁治疗神经病理性疼痛是安全有效的。已发表的试验报告和基于已发表试验报告的系统评价误导了患者和医务人员，因为有关加巴喷丁危害的信息仅部分公布。我们已确认药物开发商进行的试验已被放弃，我们计划在恢复试验支持中心的支持下进行恢复（https://restoringtrials.org/）。
在这项研究中，我们将分析和报告未公开报告的（例如，在期刊文章中）六次加巴喷丁试验中观察到的危害。我们将使用临床研究报告和个体参与者数据来识别和报告每个试验中观察到的危害，并总结所有六次试验中观察到的危害。我们将通过在开放科学框架（https://osf.io/w8puv/）上共享去识别数据和汇总表来报告纳入试验中观察到的所有不良事件。此外，我们将生成一份总结报告，描述每个试验中随机组之间以及各试验之间预定危害结局的差异。
我们将使用二级数据。这项研究被确定为免除机构审查委员会（IRB）审查（方案编号 1910607198）。
