Clinical Trial Results:
A 6-week open label cross-over study with 2 different daily doses of Minirin oral lyophilisate (120 µg and 240 µg) and 2 different daily doses of Minirin tablet (0.2 mg and 2 x 0.2 mg) in children and adolescents with primary nocturnal enuresis (PNE)
Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines
Summary
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EudraCT number |
2004-000593-32 |
Trial protocol |
DE SE FI DK GB |
Global completion date |
12 Sep 2005
|
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? |
Yes
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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 |
30 Oct 2016
|
First version publication date |
30 Oct 2016
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Other versions |
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Summary report(s) |
FE 992026 CS022 summary report |
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.