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Safety of Daily Dose Esomeprazole for GERD for Pediatric and Adolescent Patients

NCT00241501 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2010-11-19

No results posted yet for this study

Summary

This study is a phase III, multi-centre, randomized, double-blind study to assess the safety and tolerability of once daily treatment with esomeprazole 20 or 40 mg in pediatric and adolescent patients 12 to 17 years of age, inclusive, with clinically diagnosed GERD. The treatment period will be up to 8 weeks.

Conditions

  • Gastroesophageal Reflux Disease (GERD)

Interventions

DRUG

Esomeprazole (Nexium)

Sponsors & Collaborators

Principal Investigators

  • AstraZeneca Nexium Medical Sciences Director, MD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Completion
2005-04-30

Countries

  • United States
  • Canada
  • France
  • Italy

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00241501 on ClinicalTrials.gov