Clinical Trial Results:
A randomised, double-blind, double-dummy, parallel-group multicentre study to demonstrate non-inferiority in pain and locomotor function and improvement in symptoms of constipation in subjects with moderate to severe pain due to osteoarthritis (OA) of the knee and/or hip taking oxycodone equivalent of 20 - 80 mg/day as oxycodone/naloxone prolonged release (OXN PR) compared to subjects taking oxycodone prolonged release tablets (OxyPR) alone.
Summary
|
|
EudraCT number |
2008-002670-36 |
Trial protocol |
DE CZ HU NL ES AT FI BE |
Global completion date |
02 Aug 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 |
v1(current) |
This version publication date |
28 May 2016
|
First version publication date |
28 May 2016
|
Other versions |
|
Summary report(s) |
OXN3503 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.