Clinical Trial Results:
A double-blind, randomized, 6-week, parallel-group clinical
trial to assess the safety and efficacy of Asacol 4.8 g/day
(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mg
mesalamine tablet) for the treatment of moderately active
ulcerative colitis (ASCEND III)
Summary
|
|
EudraCT number |
2006-001310-32 |
Trial protocol |
EE LT CZ HU LV |
Global completion date |
01 Jan 2006
|
Paediatric regulatory details
|
|
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
|
|
Results version number |
v1(current) |
This version publication date |
26 Jun 2022
|
First version publication date |
26 Jun 2022
|
Other versions |
|
Summary report(s) |
Justification Letter |
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.