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

Gastroesophageal Reflux Disease (GERD) Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00241501
• Other study ID #: D9614C00098
• Status: Completed
• Phase: Phase 3
• First received: October 18, 2005
• Last updated: November 18, 2010
• Start date: February 2004
• Est. completion date: April 2005

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease (GERD)

Intervention

Drug:
• Esomeprazole (Nexium)

Locations

Country	Name	City	State
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Hamilton	Ontario
Canada	Research Site	Mount Pearl	Newfoundland and Labrador
Canada	Research Site	Oakville	Ontario
Canada	Research Site	Parkdale	Prince Edward Island
Canada	Research Site	Scarborough	Ontario
Canada	Research Site	Sudbury	Ontario
France	Research Site	Lille
France	Research Site	Paris
France	Research Site	Tours
Italy	Research Site	Genova	GE
Italy	Research Site	Roma
United States	Research Site	Atlanta	Georgia
United States	Research Site	Binghamton	New York
United States	Research Site	Boston	Massachusetts
United States	Research Site	Bronx	New York
United States	Research Site	Brooklyn	New York
United States	Research Site	Buffalo	New York
United States	Research Site	Burlington	Vermont
United States	Research Site	Chattanooga	Tennessee
United States	Research Site	Cleveland	Ohio
United States	Research Site	Dayton	Ohio
United States	Research Site	Detroit	Michigan
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Iowa City	Iowa
United States	Research Site	Jackson	Mississippi
United States	Research Site	Johnson City	New York
United States	Research Site	Little Rock	Arkansas
United States	Research Site	New Hyde Park	New York
United States	Research Site	Norfolk	Virginia
United States	Research Site	Orlando	Florida
United States	Research Site	Park Ridge	Illinois
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Phoenix	Arizona
United States	Research Site	Plymouth	Minnesota
United States	Research Site	Shreveport	Louisiana
United States	Research Site	St Paul	Minnesota
United States	Research Site	Waltham	Massachusetts
United States	Research Site	Wilmington	Delaware
United States	Research Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Canada,  France,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate safety & how tolerable a once daily treatment with esomeprazole is in pediatric & adolescent patients
Primary	12 to 17 years of age, inclusive, with clinically diagnosed Gastroesophageal Reflux Disease (G
Secondary	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
Secondary	- Assessment of changes from baseline in daily patient symptom assessment as reported by the patient.
Secondary	- Assessment of changes from baseline in Physician Global Assessment.