Clinical Trial Results:
Single-dose, multicenter, randomized, double-blind, double-dummy, parallel group study to assess the efficacy and safety of oral palonosetron 0.50 mg compared to I.V. palonosetron 0.25 mg administered with dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in cancer patients receiving highly emetogenic cisplatin-based chemotherapy
Summary
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EudraCT number |
2010-022223-29 |
Trial protocol |
HU DE PL IT BG |
Global completion date |
14 Nov 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 |
24 Jul 2016
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First version publication date |
24 Jul 2016
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Other versions |
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Summary report(s) |
PALO-10-01 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.