Clinical Trial Results:
An Open-label, Single-Dose, Three-way Crossover Study to Compare the Pharmacokinetics of Fixed-Dose Combination of Mometasone + Azelastine Nasal Spray to Mometasone and Azelastine Nasal Sprays in Adolescents (12 to 17 years of age) and Young Adults (18 to 24 years of age) with Seasonal
Allergic Rhinitis
Other PIP decision number: P/020/2023
Summary
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EudraCT number |
2023-000362-34 |
Trial protocol |
Outside EU/EEA |
Global completion date |
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
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Results information
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Results version number |
v1(current) |
This version publication date |
14 Apr 2024
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First version publication date |
14 Apr 2024
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Other versions |
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Summary report(s) |
Results 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.