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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-004534-40-BE
Enrollment
Unknown
Registered
2006-12-04
Start date
2007-03-06
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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 Spon

Sponsors

Wyeth Research Division of Wyeth Pharmaceuticals Inc, Clinical Research and Development
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Main Objective: ;Secondary Objective: ;Primary end point(s):—

Countries

Belgium, France, Germany, Latvia

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026