Esomeprazole for Treatment of GERD in Pediatric Patients

Gastroesophageal Reflux Disease (GERD) Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00228527
• Other study ID #: D9614C00097
• Status: Completed
• Phase: Phase 4
• First received: September 27, 2005
• Last updated: November 18, 2010
• Start date: October 2004
• Est. completion date: October 2005

Study information

• Verified date: November 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To look at the safety and improvement in symptoms of a once a day dosing of esomeprazole in children 1 to 11 years old with inflammation of their esophagus or food pipe ("esophagitis") caused by gastroesophageal reflux disease (GERD) and diagnosed by endoscopy.

To verify the healing of the esophageal inflammation if the endoscopy reveals cuts in the lining of the food pipe.

To collect information that will describe the psychological, social, and economic effects on the primary caregiver of raising children ages 1 to 5 years old with GERD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 11 Years

Eligibility

Inclusion Criteria:

• Patients' parents/guardians must provide written informed consent prior to the execution of any study-related procedures.

• Patients who are able to comprehend their involvement in a clinical study, including risks and benefits, (typically =6 years of age) must have assent documented by study personnel prior to any study-related procedures.

• Patients must be diagnosed with endoscopically proven GERD by the investigator during the screening period or have a previous (within 2 weeks prior to Visit 1) diagnosis of erosive esophagitis by endoscopy and are candidates for PPI therapy.

Exclusion Criteria:

• Patients who have used a proton pump inhibitor within 14 days prior to randomization, including over-the-counter omeprazole.

• Patients who have used any prescription or over-the-counter (OTC) treatment (other than proton pump inhibitors) for symptoms of GERD, such as histamine 2 receptor antagonists or prokinetics, within 72 hours prior to randomization.

• 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

• Erosive Esophagitis
• Esophagitis
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease (GERD)
• Non-erosive Esophagitis

Intervention

Drug:
• Esomeprazole (Nexium)

Locations

Country	Name	City	State
Belgium	Research Site	Brussels
Belgium	Research Site	Brussels (Jette)
Belgium	Research Site	Brussels (Laeken)
Belgium	Research Site	Brussels (Woluwé-St-Lambert)
Belgium	Research Site	Leuven
France	Research Site	Lille
France	Research Site	Paris
France	Research Site	Tours
Italy	Research Site	Genova	GE
Italy	Research Site	Napoli
Italy	Research Site	Parma	PR
Italy	Research Site	Roma	RM
United States	Research Site	Boston	Massachusetts
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	Chicago	Illinois
United States	Research Site	Columbus	Ohio
United States	Research Site	Dallas	Texas
United States	Research Site	Detroit	Michigan
United States	Research Site	Hershey	Pennsylvania
United States	Research Site	Houston	Texas
United States	Research Site	Jackson	Mississippi
United States	Research Site	Mobile	Alabama
United States	Research Site	Morristown	New Jersey
United States	Research Site	Norfolk	Virginia
United States	Research Site	Omaha	Nebraska
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	St. Louis	Missouri
United States	Research Site	Troy	Michigan
United States	Research Site	West Islip	New York
United States	Research Site	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Belgium,  France,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective of the study is to evaluate the safety of once daily treatment with esomeprazole in relieving GERD-associated symptoms in pediatric patients 1 to 11 years of age, inclusive.
Primary	The primary outcome variables include assessment of changes from baseline in medical history, physical examination, clinical laboratory evaluations, and adverse events.
Secondary	The secondary objective of the study is to evaluate the clinical outcome of once daily treatment with esomeprazole in relieving GERD-associated signs and symptoms in pediatric patients 1 to 11 years of age, inclusive.
Secondary	The secondary objectives include:
Secondary	- Assessment of changes from baseline in daily patient symptom assessment as reported by parent/guardian.
Secondary	- Assessment of changes from baseline in Physician's Global Assessment
Secondary	- Assessment of endoscopic healing of erosive esophagitis