Clinical Trial Results:
One week double-blind, randomized, placebo-controlled, parallel-group, multi-center study with Creon® 25000 Minimicrospheres™ in subjects with pancreatic exocrine
insufficiency after pancreatic surgery, followed by an open-label long-term extension of 1 year
Summary
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EudraCT number |
2005-004854-29 |
Trial protocol |
DE IT BG HU |
Global completion date |
01 Jul 2011
|
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 |
15 Aug 2019
|
First version publication date |
15 Aug 2019
|
Other versions |
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Summary report(s) |
S245.4.008-Synopsis_Redacted |
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.