Clinical Trial Results:
A randomized, double-blind, parallel-group, multicenter study to demonstrate improvement in symptoms of constipation in subjects with non-malignant pain taking oxycodone equivalent of >= 20 mg/day and <= 50 mg/day as oxycodone / naloxone prolonged release compared to subjects taking oxycodone prolonged release tablets alone.
Summary
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EudraCT number |
2005-002398-57 |
Trial protocol |
GB ES DE CZ IT |
Global completion date |
25 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 |
v4(current) |
This version publication date |
28 May 2016
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First version publication date |
07 May 2015
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Other versions |
v1 , v2 , v3 |
Version creation reason |
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Summary report(s) |
OXN3001 synopsis OXN3001S 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.