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A Phase III, Multicentre, Randomized, Double-blind Parallel-group Study to Evaluate the Safety and Clinical Outcome of Once Daily Esomeprazole for the Treatment of Gastroesophageal Reflux Disease GERD in Pediatric Patients 1 to 11 Years of Age, Inclusive

A Phase III, Multicentre, Randomized, Double-blind Parallel-group Study to Evaluate the Safety and Clinical Outcome of Once Daily Esomeprazole for the Treatment of Gastroesophageal Reflux Disease GERD in Pediatric Patients 1 to 11 Years of Age, Inclusive

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-002370-39-IT
Enrollment
100
Registered
2006-12-06
Start date
2004-12-02
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

Gastroesophageal Reflux Disease GERD MedDRA version: 6.1 Level: PT Classification code 10017885

Interventions

Product Name: ESOMEPAZOLE Pharmaceutical Form: Capsule, hard INN or Proposed INN: Esomeprazole Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Product Name: ES

Sponsors

ASTRAZENECA
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) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

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

Countries

Italy

Outcome results

None listed

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