P4 (Pregabalin for Peripheral Posttraumatic Pain)

Phase 4 Completed 255 enrolled Viatris Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

To evaluate the efficacy of pregabalin compared to placebo in the treatment of posttraumatic peripheral neuropathic pain

Timeline

Start: 2006-01
Primary completion: 2008-05
Completion: 2008-05

Outcome

Met primary endpoint

registry LEAST_SQUARES_MEAN Pregabalin: 4.61 (Standard Error 0.18) score on a scale LEAST_SQUARES_MEAN Placebo: 5.23 (Standard Error 0.18) score on a scale NCT00292188 ↗

registry analysis (unspecified test); Pregabalin vs Placebo; p = 0.010; Mean Difference (Final Values) -0.62 (95% CI -1.09 to -0.15); ANCOVA NCT00292188 ↗

Publications

van Seventer R, Serpell M, Bach FW, Morlion B, Zlateva G, Bushmakin AG, Cappelleri JC, Nimour M. Relationships between changes in pain severity and other patient-reported outcomes: an analysis in patients with posttraumatic peripheral neuropathic pain. Health Qual Life Outcomes. 2011 Mar 25;9:17. doi: 10.1186/1477-7525-9-17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pregabalin	Small molecule	—	—