Clinical Trial Results:
An evaluation of the effectiveness and tolerability of tapentadol hydrochloride prolonged release, and tapentadol hydrochloride immediate release on demand, in subjects with uncontrolled severe chronic pain due to osteoarthritis of the knee taking either WHO Step I or Step II analgesics or no regular analgesics.
Summary
|
|
EudraCT number |
2009-010423-58 |
Trial protocol |
GB ES DE FR |
Global completion date |
02 Sep 2010
|
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 |
v2(current) |
This version publication date |
07 Apr 2016
|
First version publication date |
30 Jul 2015
|
Other versions |
v1 |
Version creation reason |
|
Summary report(s) |
ICH E3 redacted extended 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.