Clinical Trial Results:
A multi-center, double-blind, randomized, active reference, parallel group study to evaluate the efficacy, safety and tolerability of a 10-day twice daily oral administration of 3 doses of ACT-179811 in subjects with Clostridium difficile infection (CDI)
Summary
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EudraCT number |
2010-020941-29 |
Trial protocol |
SE DE GB IT |
Global completion date |
12 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 |
26 Nov 2016
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First version publication date |
26 Nov 2016
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Other versions |
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Summary report(s) |
AC-061A201 CSR 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.