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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
140
To evaluate safety & how tolerable a once daily treatment with esomeprazole is in pediatric & adolescent patients
12 to 17 years of age, inclusive, with clinically diagnosed Gastroesophageal Reflux Disease (G
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
- Assessment of changes from baseline in daily patient symptom assessment as reported by the patient.
- Assessment of changes from baseline in Physician Global Assessment.
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Research Site
Phoenix, Arizona, United States
Research Site
Little Rock, Arkansas, United States
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Wilmington, Delaware, United States
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Orlando, Florida, United States
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Atlanta, Georgia, United States
Research Site
Park Ridge, Illinois, United States
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Indianapolis, Indiana, United States
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Iowa City, Iowa, United States
Research Site
Shreveport, Louisiana, United States
Research Site
Boston, Massachusetts, United States
...and 30 more locations