Status:
COMPLETED
Safety of Daily Dose Esomeprazole for GERD for Pediatric and Adolescent Patients
Lead Sponsor:
AstraZeneca
Conditions:
Gastroesophageal Reflux Disease (GERD)
Eligibility:
All Genders
12-17 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
End Date :
April 1 2005
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00241501
Start Date
February 1 2004
End Date
April 1 2005
Last Update
November 19 2010
Active Locations (40)
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1
Research Site
Phoenix, Arizona, United States
2
Research Site
Little Rock, Arkansas, United States
3
Research Site
Wilmington, Delaware, United States
4
Research Site
Orlando, Florida, United States