Clinical Trial Results:
A dose titrated clinical trial with a placebo-controlled, double-blind, randomised, cross-over phase to demonstrate the efficacy of 400 μg Intranasal fentanyl (INFS) dose strength, and to evaluate 12 weeks safety and nasal tolerability of all dose strengths between 50 μg and 400 μg, in cancer patients with breakthrough pain
Summary
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EudraCT number |
2010-021096-85 |
Trial protocol |
HU |
Global completion date |
04 Jan 2013
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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 |
24 Jun 2016
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First version publication date |
24 Jun 2016
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Other versions |
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Summary report(s) |
Results Disclosure |
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.