Markman, John http://orcid.org/0000-0001-6296-8998
Resnick, Malca
Greenberg, Scott
Katz, Nathaniel
Yang, Ruoyong
Scavone, Joseph
Whalen, Ed
Gregorian, Gabriela
Parsons, Bruce
Knapp, Lloyd
Clinical trials referenced in this document:
Documents that mention this clinical trial
Efficacy of pregabalin in post-traumatic peripheral neuropathic pain: a randomized, double-blind, placebo-controlled phase 3 trial
https://doi.org/10.1007/s00415-018-9063-9
Funding for this research was provided by:
Pfizer
Article History
Received: 15 April 2018
Revised: 17 August 2018
Accepted: 16 September 2018
First Online: 21 September 2018
Compliance with ethical standards
:
: The protocol complied with the Declaration of Helsinki (1964), and was reviewed and approved by the institutional review board at each participating center.
: All participants provided written, informed consent.
: JM has participated in advisory boards (Pfizer, Editas Medicine, Flexion Therapeutics, Teva, Quark, Pacira, Inspirion Delivery Sciences, Quartet, Pacira Egalet, Biogen, Nektar, Endo, Immune Pharma, Chromocell, Collegium, Purdue, Novartis, Sanofi, Convergence, Aptinyx, Daiichi Sankyo, Allergan, Plasmasurgical, and Grunenthal), received research funding (Depomed, Pfizer), and served on Data Safety Monitoring Boards (Allergan, Novartis). M Resnick, R Yang, J Scavone, E Whalen, G Gregorian, B Parsons, and L Knapp are employees of Pfizer Inc. S Greenberg was an employee of Pfizer at the time of the study and development of the manuscript. N Katz is employed by Analgesic Solutions, which provided a central eligibility verification service to identify patients with PTNP.
: Upon request, and subject to certain criteria, conditions and exceptions (see ExternalRef removed for more information), Pfizer will provide access to individual de-identified participant data from Pfizer-sponsored global interventional clinical studies conducted for medicines, vaccines and medical devices (1) for indications that have been approved in the US and/or EU or (2) in programs that have been terminated (i.e., development for all indications has been discontinued). Pfizer will also consider requests for the protocol, data dictionary, and statistical analysis plan. Data may be requested from Pfizer trials 24 months after study completion. The de-identified participant data will be made available to researchers whose proposals meet the research criteria and other conditions, and for which an exception does not apply, via a secure portal. To gain access, data requestors must enter into a data access agreement with Pfizer.