Clinical Trial Results:
A MULTICENTER, OPEN-LABEL PHARMACOKINETIC, PHARMACODYNAMIC,
CLINICAL SYMPTOMS, AND SAFETY STUDY OF PANTOPRAZOLE DELAYED-RELEASED
GRANULES ADMINISTERED AS A SUSPENSION IN NEONATES AND
PRETERM INFANTS WITH A CLINICAL DIAGNOSIS OF GASTROESOPHAGEAL
REFLUX DISEASE
Summary
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EudraCT number |
2006-001473-24 |
Trial protocol |
BE FR IT NL |
Global completion date |
20 Dec 2007
|
Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
|
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 Aug 2016
|
First version publication date |
24 Aug 2016
|
Other versions |
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Summary report(s) |
3001B3-331-WW_B1791057_Public Disclosure 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.