Clinical Trial Results:
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
Summary
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EudraCT number |
2011-005216-28 |
Trial protocol |
DE GB PL |
Global completion date |
22 Aug 2012
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
08 Mar 2018
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First version publication date |
08 Mar 2018
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Other versions |
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Summary report(s) |
115640-Clinical-Study-Result-Summary |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.