Clinical Trial Results:
A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluate
the Effect of Remission Status on the Ability to Maintain or Achieve
Clinical and Endoscopic Remission During a 12-Month, Long-term
Maintenance Phase With 2.4g/day MMX® Mesalamine/mesalazine
Once Daily in Adult Subjects With Ulcerative Colitis
Summary
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|
EudraCT number |
2009-017044-13 |
Trial protocol |
GB ES IE HU BE CZ DE FR |
Global completion date |
14 Dec 2012
|
Paediatric regulatory details
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|
Is the trial part of an agreed EMA paediatric investigation plan? |
No
|
Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
|
Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
|
Results information
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|
Results version number |
v1(current) |
This version publication date |
12 Jul 2018
|
First version publication date |
20 Dec 2014
|
Other versions |
|
Summary report(s) |
SPD476-409 |
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.