Efficacy And Safety Of Pregabalin For Pain Following Total Knee Replacement

Phase 3 Completed 307 enrolled Viatris Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

Pregabalin added to the standard of care with dosing starting preoperatively and continuing for up to 6 weeks post surgery will decrease the intensity of post-operative pain following total knee replacement.

Timeline

Start: 2007-05
Primary completion: 2008-12
Completion: 2008-12

Outcome

Missed primary endpoint

paper There were no statistically significant differences between the pregabalin and placebo groups with respect to the primary endpoint in any of the three trials. PMID 25565885 ↗

registry Pregabalin (300 mg) vs Placebo; p = 0.3619; Mean Difference (Final Values) -0.339 (95% CI -1.070 to 0.392) NCT00442546 ↗

Publications

Singla NK, Chelly JE, Lionberger DR, Gimbel J, Sanin L, Sporn J, Yang R, Cheung R, Knapp L, Parsons B. Pregabalin for the treatment of postoperative pain: results from three controlled trials using different surgical models. J Pain Res. 2014 Dec 23;8:9-20. doi: 10.2147/JPR.S67841. eCollection 2015.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pregabalin	Small molecule	150 mg	—
Subject	Pregabalin	Small molecule	300 mg	—