Single Dose IV Push Study in Patients with PONV
Research type
Research Study
Full title
A Multicenter, Randomized, Single-blind, Active-controlled, Parallel Group, Phase II Study to Evaluate the Efficacy, Safety, and Tolerability of a Single Intravenous (6 mg, 12 mg, 18 mg, 24 mg or 36 mg) Dose of the Neurokinin-1 Receptor Antagonist, Vestipitant (GW597599), Compared with a Single 4 mg Intravenous Ondansetron Hydrochloride Dose for the Treatment of Breakthrough Post-Operative Nausea and Vomiting after Failed Prophylaxis with an Ondansetron-Containing Regimen in Patients Undergoing Non-Emergency Surgical Procedures
IRAS ID
97648
Contact name
Jonathan Thompson
Sponsor organisation
Aptiv Solutions on behalf of GSK
Eudract number
2011-005216-28
Clinicaltrials.gov Identifier
Research summary
Vestipitant (GW597599) is a potent and selective Neurokinin 1 receptor (NK1) antagonist. It has been studied as a medication to overcome post-operative nausea and vomiting (PONV) and other indications. To date, 2054 subjects have received vestipitant in both oral and intravenous forms in 39 Phase I and II studies. Two studies have explored vestipitant specifically for PONV. Study VNK225640 will evaluate 5 doses of i.v. vestipitant (6mg, 12mg, 18mg, 24mg and 36mg) against a standard 4mg dose of i.v. ondansetron to treat PONV that emerges after surgery and after a prophylactic dose of ondansetron 4mg i.v. i.e. treatment of breakthrough PONV. The study will explore the efficacy of vestipitant against ondansetron defined as a Complete Response after receiving medication to treat breakthrough PONV. Complete response is defined as no vomiting or further rescue medication >10 minutes after infusion of study medication. Additional efficacy endpoints will explore the patients perception of nausea, using the Nausea Numeric Rating Scale (NNRS) ranked 0 to 10 as well the time to hospital discharge. Data from this study will also explore the pharmacokinetic parameters of vestipitant in patients.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
12/SC/0079
Date of REC Opinion
15 Mar 2012
REC opinion
Further Information Favourable Opinion