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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: October 18, 2005
Last updated: November 18, 2010
Last verified: November 2010
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.

Condition Intervention Phase
Gastroesophageal Reflux Disease (GERD)
Drug: Esomeprazole (Nexium)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase III, Multicentre, Randomized, Double-blind, Parallel-group Study to Evaluate the Safety of Once Daily Esomeprazole for the Treatment of Clinically Diagnosed Gastroesophageal Reflux Disease (GERD) in Pediatric and Adolescent Patients 12 to 17 Years of Age, Inclusive.

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Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To evaluate safety & how tolerable a once daily treatment with esomeprazole is in pediatric & adolescent patients
  • 12 to 17 years of age, inclusive, with clinically diagnosed Gastroesophageal Reflux Disease (G

Secondary Outcome Measures:
  • To evaluate the clinical outcome of once daily treatment with esomeprazole in relieving gastroesophageal reflux disease (GERD)-associated signs & symptoms in pediatric & adolescent patients 12 to 17 years of age
  • - Assessment of changes from baseline in daily patient symptom assessment as reported by the patient.
  • - Assessment of changes from baseline in Physician Global Assessment.

Estimated Enrollment: 140
Study Start Date: February 2004
Study Completion Date: April 2005

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Provision of signed written informed consent from the patient's parent/guardian, and assent from the patient prior to conducting of any study-related procedures.
  • Patients must be male or female between the age of 12 and 17 years, inclusive.
  • Patients must have a clinical diagnosis of GERD made by the investigator based on any of the following factors: history, physical examination, review of systems, laboratory test results, or information from diagnostic testing.

Exclusion Criteria:

  • Patients who have used a PPI within 14 days prior to randomization, including over-the-counter Prilosec®.
  • Patients who have used any prescription or over-the-counter treatment for symptoms of gastroesophageal reflux disease (GERD), such as Histamine 2 Receptor Antagonists (H2RA) or prokinetics, within 3 days prior to randomization. Antacids may be used, except for those containing bismuth.
  • Patients with a known hypersensitivity, allergy, or intolerance to any component of esomeprazole or omeprazole.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00241501

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Sponsors and Collaborators
Study Director: AstraZeneca Nexium Medical Sciences Director, MD AstraZeneca
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00241501     History of Changes
Other Study ID Numbers: D9614C00098 
Study First Received: October 18, 2005
Last Updated: November 18, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Proton Pump Inhibitors processed this record on May 26, 2016