Clinical Trial Results:
Efficacy and safety of Dexa-Polyspectran® drops, preserved with benzalkonium chloride, vs. Dexa-Polyspectran® drops without dexamethasone phosphate, preserved with benzalkonium chloride, in patients with acute bacterial otitis externa – A double-blind, multicenter, prospective, randomized, controlled clinical phase III study.
Summary
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EudraCT number |
2005-001179-36 |
Trial protocol |
DE |
Global completion date |
17 Jul 2006
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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 |
22 Sep 2016
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First version publication date |
22 Sep 2016
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Other versions |
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Summary report(s) |
C-04-72 Technical Summary of Results |
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.