A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, TREATMENT-WITHDRAWAL STUDY OF THE EFFICACY AND SAFETY OF PANTOPRAZOLE SODIUM ENTERIC-COATED GRANULES IN INFANTS (1 THROUGH 11 MONTHS) WITH ...

Update Il y a 5 ans
Reference: EUCTR2005-004534-40

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, TREATMENT-WITHDRAWAL STUDY OF THE EFFICACY AND SAFETY OF PANTOPRAZOLE SODIUM ENTERIC-COATED GRANULES IN INFANTS (1 THROUGH 11 MONTHS) WITH SYMPTOMATIC GERD

Woman and Man

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Extract

To assess the efficacy of treatment with pantoprazole granules administered as a suspension in pediatric patients 1 through 11 months of age. The difference in withdrawal rates will compared between the two groups.


Inclusion criteria

  • Treatment of gastroesophageal reflux disease (GERD) symptoms in infants 1 through 11 months