Clinical Trial Results:
A confirmatory, placebo-controlled, randomised, double-blind, single-dummy, parallel group, ratio-finding study in constipated pain patients to establish an optimal hydromorphone – naloxone ratio with an improved bowel function and a comparable analgesic efficacy compared to hydromorphone alone
Summary
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EudraCT number |
2008-005315-18 |
Trial protocol |
CZ FI GB FR NL DE AT BE DK RO |
Global completion date |
05 Jan 2012
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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 |
21 Dec 2016
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First version publication date |
21 Dec 2016
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Other versions |
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Summary report(s) |
HMX3501 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.