Clinical trial NCT00228527: Esomeprazole for Treatment of GERD in Pediatric Patients
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastroesophageal Reflux Disease (GERD)
Erosive Esophagitis
Non-erosive Esophagitis
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-29
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: 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.
measure: The primary outcome variables include assessment of changes from baseline in medical history, physical examination, clinical laboratory evaluations, and adverse events.
Secondary outcomes:
measure: 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.
measure: The secondary objectives include:
measure: - Assessment of changes from baseline in daily patient symptom assessment as reported by parent/guardian.
measure: - Assessment of changes from baseline in Physician's Global Assessment
measure: - Assessment of endoscopic healing of erosive esophagitis
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Research Site
state: Alabama
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Wilmington
country: United States
facility: Research Site
state: Delaware
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Park Ridge
country: United States
facility: Research Site
state: Illinois
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Detroit
country: United States
facility: Research Site
state: Michigan
city: Troy
country: United States
facility: Research Site
state: Michigan
city: Jackson
country: United States
facility: Research Site
state: Mississippi
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Morristown
country: United States
facility: Research Site
state: New Jersey
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: Buffalo
country: United States
facility: Research Site
state: New York
city: West Islip
country: United States
facility: Research Site
state: New York
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Hershey
country: United States
facility: Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Chattanooga
country: United States
facility: Research Site
state: Tennessee
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Burlington
country: United States
facility: Research Site
state: Vermont
city: Norfolk
country: United States
facility: Research Site
state: Virginia
city: Brussels (Jette)
country: Belgium
facility: Research Site
city: Brussels (Laeken)
country: Belgium
facility: Research Site
city: Brussels (Woluwé-St-Lambert)
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Lille
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Tours
country: France
facility: Research Site
city: Genova
country: Italy
facility: Research Site
state: GE
city: Parma
country: Italy
facility: Research Site
state: PR
city: Roma
country: Italy
facility: Research Site
state: RM
city: Napoli
country: Italy
facility: Research Site
Study officials:
References:
citation: 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. 2015 Jul;60 Suppl 1:S31-6. doi: 10.1097/MPG.0b013e3181ddcf11.
citation: 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. J Pediatr Gastroenterol Nutr. 2015 Jul;60 Suppl 1:S24-30. doi: 10.1097/01.mpg.0000469419.29000.94.
citation: 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. 2015 Jul;60 Suppl 1:S31-6. doi: 10.1097/MPG.0b013e3181ddcf11.
citation: 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. J Pediatr Gastroenterol Nutr. 2015 Jul;60 Suppl 1:S24-30. doi: 10.1097/01.mpg.0000469419.29000.94.
citation: 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. doi: 10.1097/MPG.0b013e3181ddcf11.
citation: 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. doi: 10.1186/1471-2431-10-41.
citation: 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. doi: 10.1097/MPG.0b013e318176b2cb.