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Clinical Trial Results:
A Multicentre, Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel Group, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Oral (25 mg) and Intravenous (3 mg and 18 mg) Formulations of the Neurokinin-1 Receptor Antagonist, GW597599, When Administered with Intravenous Ondansetron Hydrochloride for the Prevention of Post-operative Nausea and Vomiting and Post-discharge Nausea and Vomiting in Female Subjects with Known Risk Factors for PONV
| Summary | |
EudraCT number | 2004-001021-22 |
Trial protocol | FI CZ |
Global completion date | 11 Jul 2006 |
| Paediatric regulatory details | |
Is the trial part of an agreed EMA paediatric investigation plan? | No |
Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? | No |
Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? | No |
| Results information | |
Results version number | v1(current) |
This version publication date | 25 Nov 2016 |
First version publication date | 25 Nov 2016 |
Other versions | |
Summary report(s) | gsk-101287-synopsis-redact |
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.