Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo For Treatment Of Post-Surgical Pain From Hysterectomy

Phase 3 Completed 501 enrolled Viatris Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

To assess the efficacy of pregabalin compared to placebo on pain following hysterectomy , measured using subject reported assessments of pain.

Timeline

Start: 2007-06
Primary completion: 2010-05
Completion: 2010-10

Outcome

Missed primary endpoint

registry analysis (unspecified test); Pregabalin 300 mg vs Placebo; p = 0.4710; ANOVA; NCT00468845 ↗

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 ↗

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	—