Gastroesophageal Reflux Disease (GERD)
Conditions
Brief summary
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.
Interventions
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Provision of signed written informed consent from the patient's parent/guardian, and assent from the patient prior to conducting of any study-related procedures. * Patients must be male or female between the age of 12 and 17 years, inclusive. * Patients must have a clinical diagnosis of GERD made by the investigator based on any of the following factors: history, physical examination, review of systems, laboratory test results, or information from diagnostic testing.
Exclusion criteria
* Patients who have used a PPI within 14 days prior to randomization, including over-the-counter Prilosec®. * Patients who have used any prescription or over-the-counter treatment for symptoms of gastroesophageal reflux disease (GERD), such as Histamine 2 Receptor Antagonists (H2RA) or prokinetics, within 3 days prior to randomization. Antacids may be used, except for those containing bismuth. * Patients with a known hypersensitivity, allergy, or intolerance to any component of esomeprazole or omeprazole.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Canada, France, Italy, United States
Outcome results
None listed