Clinical Trial Results:
A multicenter, open-label trial to assess cognitive and psychomotor performance as surrogate parameters for driving ability under stable long term treatment with tapentadol hydrochloride prolonged-release tablets in subjects with chronic low back pain or osteoarthritis of the knee.
Summary
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EudraCT number |
2009-015397-35 |
Trial protocol |
DE |
Global completion date |
03 Sep 2010
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
25 Feb 2016
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First version publication date |
30 Jul 2015
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Other versions |
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Summary report(s) |
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.