Safety of Daily Dose Esomeprazole for GERD for Pediatric and Adolescent Patients
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|ClinicalTrials.gov Identifier: NCT00241501|
Recruitment Status : Completed
First Posted : October 19, 2005
Last Update Posted : November 19, 2010
|Condition or disease||Intervention/treatment||Phase|
|Gastroesophageal Reflux Disease (GERD)||Drug: Esomeprazole (Nexium)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Phase III, Multicentre, Randomized, Double-blind, Parallel-group Study to Evaluate the Safety of Once Daily Esomeprazole for the Treatment of Clinically Diagnosed Gastroesophageal Reflux Disease (GERD) in Pediatric and Adolescent Patients 12 to 17 Years of Age, Inclusive.|
|Study Start Date :||February 2004|
|Actual Study Completion Date :||April 2005|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00241501
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|Study Director:||AstraZeneca Nexium Medical Sciences Director, MD||AstraZeneca|