Esomeprazole for Treatment of GERD in Pediatric Patients
|ClinicalTrials.gov Identifier: NCT00228527|
Recruitment Status : Completed
First Posted : September 29, 2005
Last Update Posted : November 19, 2010
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 or disease||Intervention/treatment||Phase|
|Gastroesophageal Reflux Disease (GERD) Erosive Esophagitis Non-erosive Esophagitis||Drug: Esomeprazole (Nexium)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|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 Start Date :||October 2004|
|Actual Study Completion Date :||October 2005|
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00228527
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