Clinical Trial Results:
A two part protocol to assess, using double blind placebo control, the safety, tolerability, and pharmacokinetics of ascending single doses of a new intra-articular administration formulation of SAR113945 (IKK inhibitor) followed by assessment of efficacy, safety, tolerability and pharmacokinetics of a single dose in patients with knee osteoarthritis.
Summary
|
|
EudraCT number |
2011-003232-31 |
Trial protocol |
DE |
Global completion date |
05 Feb 2013
|
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 |
17 Nov 2016
|
First version publication date |
17 Nov 2016
|
Other versions |
|
Summary report(s) |
TDU11685 ACT12505 |
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.