A Study of Vestipitant (GW597599) in the Treatment of Breakthrough Postoperative Nausea and Vomiting (PONV)

Phase 2 Completed 131 enrolled Accenture

RandomizedParallel-groupSingle-blindTreatment

Summary

This study will evaluate single IV doses of Vestipitant (GW597599) compared to 4 mg IV ondansetron for treating breakthrough postoperative nausea and vomiting (PONV) after failure of PONV prophylaxis with a regimen that includes 4 mg IV ondansetron.

Timeline

Start: 2012-02
Primary completion: 2012-08
Completion: 2012-08

Outcome

Met primary endpoint

paper All doses of vestipitant were non-inferior to ondansetron in treating PONV after failed prophylaxis with ondansetron. PMID 25488303 ↗

Publications

Kranke P, Thompson JP, Dalby PL, Eberhart LH, Novikova E, Johnson BM, Russ SF, Noble R, Brigandi RA. Comparison of vestipitant with ondansetron for the treatment of breakthrough postoperative nausea and vomiting after failed prophylaxis with ondansetron. Br J Anaesth. 2015 Mar;114(3):423-9. doi: 10.1093/bja/aeu376. Epub 2014 Dec 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Ondansetron	Other / unclassified	4 mg	Intravenous
Subject	Vestipitant	Small molecule	6 mg	Intravenous
Subject	Vestipitant	Small molecule	12 mg	Intravenous
Subject	Vestipitant	Small molecule	18 mg	Intravenous
Subject	Vestipitant	Small molecule	24 mg	Intravenous
Subject	Vestipitant	Small molecule	36 mg	Intravenous

Indications

No indication recorded.