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Safety of Daily Dose Esomeprazole for GERD for Pediatric and Adolescent Patients

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00241501
First received: October 18, 2005
Last updated: November 18, 2010
Last verified: November 2010
History of Changes

October 18, 2005
November 18, 2010
February 2004
Not Provided
  • 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
Same as current
Complete list of historical versions of study NCT00241501 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Safety of Daily Dose Esomeprazole for GERD for Pediatric and Adolescent Patients
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.

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Gastroesophageal Reflux Disease (GERD)
Drug: Esomeprazole (Nexium)
Not Provided
Gunasekaran T, Tolia V, Colletti RB, Gold BD, Traxler B, Illueca M, Crawley JA. Effects of esomeprazole treatment for gastroesophageal reflux disease on quality of life in 12- to 17-year-old adolescents: an international health outcomes study. BMC Gastroenterol. 2009 Nov 18;9:84.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
April 2005
Not Provided

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.
Both
12 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   France,   Italy
 
NCT00241501
D9614C00098
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: AstraZeneca Nexium Medical Sciences Director, MD AstraZeneca
AstraZeneca
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP