Clinical Trial Results:
A Phase 3, Randomized, Active-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of EN3348 (MCC) as Compared with Mitomycin C in the Intravesical Treatment of Subjects with BCG Recurrent or Refractory Non-Muscle Invasive Bladder Cancer
Summary
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EudraCT number |
2011-003496-11 |
Trial protocol |
PL GB DE NL |
Global completion date |
04 Feb 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 |
15 Jul 2016
|
First version publication date |
15 Jul 2016
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Other versions |
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Summary report(s) |
EN3348-303-CSR_Synopsis_21FEB2014_v3.0 |
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.