WHO ICTRP trial

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED…

EUCTR2005-004534-40-BE · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2005-004534-40-BE
Public title 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.
Scientific title 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.
Primary sponsor Wyeth Research Division of Wyeth Pharmaceuticals Inc, Clinical Research and Development
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Countries Germany;Belgium;France;Latvia
Conditions Treatment of gastroesophageal reflux disease (GERD) symptoms in infants 1 through 11 months
Interventions Product Name: Pantoprazole Sodium Delayed-Release Granules Plus Inactive Powder Blend Pharmaceutical Form: Gastro-resistant granules INN or Proposed INN: Pantoprazole Sodium Sesquihydrate Current Sponsor code: WAY-140951 Concentration unit…
Registration date Apr 12, 2006
Secondary IDs 3001B3-329-WW
Registry page clinicaltrialsregister.eu

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