Clinical Trial Results:
A Randomized, Double-blind, Multicenter, Parallel Group, Balanced, Stratified Phase 3 Study to Evaluate the Efficacy and the Safety of Single IV Doses of Palonosetron 0.025 mg, 0.050 mg, and 0.075 mg versus Placebo to Prevent Postoperative Nausea and Vomiting Following Elective Gynecologic or Breast Surgery
Summary
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EudraCT number |
2005-000298-23 |
Trial protocol |
CZ DE |
Global completion date |
05 May 2006
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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 |
22 Jul 2016
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First version publication date |
22 Jul 2016
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Other versions |
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Summary report(s) |
PALO-04-07 synopsis |
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.