Esomeprazole for Treatment of GERD in Pediatric Patients - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00228527

Purpose

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.

Condition	Intervention	Phase
Gastroesophageal Reflux Disease (GERD) Erosive Esophagitis Non-erosive Esophagitis	Drug: Esomeprazole (Nexium)	Phase IV

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 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.

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy GERD

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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.
The primary outcome variables include assessment of changes from baseline in medical history, physical examination, clinical laboratory evaluations, and adverse events.

Secondary Outcome Measures:

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.
The secondary objectives include:
- Assessment of changes from baseline in daily patient symptom assessment as reported by parent/guardian.
- Assessment of changes from baseline in Physician's Global Assessment
- Assessment of endoscopic healing of erosive esophagitis

Estimated Enrollment:	100
Study Start Date:	October 2004
Study Completion Date:	October 2005

Eligibility

Ages Eligible for Study:	1 Year to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00228527

Show 36 Study Locations

Sponsors and Collaborators

AstraZeneca

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tolia V, Gilger MA, Barker PN, Illueca M. Healing of erosive esophagitis and improvement of symptoms of gastroesophageal reflux disease after esomeprazole treatment in children 12 to 36 months old. J Pediatr Gastroenterol Nutr. 2010 Nov;51(5):593-8.

Tolia V, Youssef NN, Gilger MA, Traxler B, Illueca M. Esomeprazole for the treatment of erosive esophagitis in children: an international, multicenter, randomized, parallel-group, double-blind (for dose) study. BMC Pediatr. 2010 Jun 11;10:41.

Gilger MA, Tolia V, Vandenplas Y, Youssef NN, Traxler B, Illueca M. Safety and tolerability of esomeprazole in children with gastroesophageal reflux disease. J Pediatr Gastroenterol Nutr. 2008 May;46(5):524-33.

ClinicalTrials.gov Identifier:	NCT00228527 History of Changes
Other Study ID Numbers:	D9614C00097
Study First Received:	September 27, 2005
Last Updated:	November 18, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Esophagitis
Gastroesophageal Reflux
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Esophageal Motility Disorders
Deglutition Disorders

Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012