Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01701362|
Recruitment Status : Completed
First Posted : October 5, 2012
Results First Posted : June 7, 2017
Last Update Posted : June 7, 2017
|Study Design||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment|
A total of 187 centers participated in the study in 14 countries.
During screening, with the exception of daily pain score data that was collected to determine participants eligibility, no participants were treated with active drug and no efficacy data were collected. Only safety and no efficacy data was collected during the taper period.
|Pre-assignment Details||Participants had clinic visits at screening, randomization, and during the treatment period, and a phone contact for follow-up after the last taper dose. All the eligible participants were randomly assigned (1:1) to 15 weeks of treatment with Pregabalin or Placebo.|