Clinical Trial Results:
Randomized, open label, comparative parallel group study to assess efficacy and safety of flexible dosages of OROS hydromorphone once-daily compared to sustained release oxycodone twice-daily in subjects with chronic non-malignant pain severe enough to require continuous opioid therapy.
Summary
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EudraCT number |
2004-005187-24 |
Trial protocol |
IT DE CZ SK |
Global completion date |
30 Apr 2008
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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 |
14 Jul 2016
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First version publication date |
14 Jul 2016
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Other versions |
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Summary report(s) |
OROSANA3001 (2004-005187-24)_Hydromorphone_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.