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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00241501
Recruitment Status : Completed
First Posted : October 19, 2005
Last Update Posted : November 19, 2010
Sponsor:
Information provided by:
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease (GERD) Drug: Esomeprazole (Nexium) Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD




Primary Outcome Measures :
  1. To evaluate safety & how tolerable a once daily treatment with esomeprazole is in pediatric & adolescent patients
  2. 12 to 17 years of age, inclusive, with clinically diagnosed Gastroesophageal Reflux Disease (G

Secondary Outcome Measures :
  1. 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
  2. - Assessment of changes from baseline in daily patient symptom assessment as reported by the patient.
  3. - Assessment of changes from baseline in Physician Global Assessment.


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, Arizona
Research Site
Phoenix, Arizona, United States
United States, Arkansas
Research Site
Little Rock, Arkansas, United States
United States, Delaware
Research Site
Wilmington, Delaware, United States
United States, Florida
Research Site
Orlando, Florida, United States
United States, Georgia
Research Site
Atlanta, Georgia, United States
United States, Illinois
Research Site
Park Ridge, Illinois, United States
United States, Indiana
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Indianapolis, Indiana, United States
United States, Iowa
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Iowa City, Iowa, United States
United States, Louisiana
Research Site
Shreveport, Louisiana, United States
United States, Massachusetts
Research Site
Boston, Massachusetts, United States
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Waltham, Massachusetts, United States
United States, Michigan
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Detroit, Michigan, United States
United States, Minnesota
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Plymouth, Minnesota, United States
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St Paul, Minnesota, United States
United States, Mississippi
Research Site
Jackson, Mississippi, United States
United States, New York
Research Site
Binghamton, New York, United States
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Bronx, New York, United States
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Brooklyn, New York, United States
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Buffalo, New York, United States
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Johnson City, New York, United States
Research Site
New Hyde Park, New York, United States
United States, North Carolina
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Winston-Salem, North Carolina, United States
United States, Ohio
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Cleveland, Ohio, United States
Research Site
Dayton, Ohio, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
United States, Tennessee
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Chattanooga, Tennessee, United States
United States, Vermont
Research Site
Burlington, Vermont, United States
United States, Virginia
Research Site
Norfolk, Virginia, United States
Canada, Newfoundland and Labrador
Research Site
Mount Pearl, Newfoundland and Labrador, Canada
Canada, Nova Scotia
Research Site
Halifax, Nova Scotia, Canada
Canada, Ontario
Research Site
Hamilton, Ontario, Canada
Research Site
Oakville, Ontario, Canada
Research Site
Scarborough, Ontario, Canada
Research Site
Sudbury, Ontario, Canada
Canada, Prince Edward Island
Research Site
Parkdale, Prince Edward Island, Canada
France
Research Site
Lille, France
Research Site
Paris, France
Research Site
Tours, France
Italy
Research Site
Genova, GE, Italy
Research Site
Roma, Italy
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: AstraZeneca Nexium Medical Sciences Director, MD AstraZeneca
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00241501    
Other Study ID Numbers: D9614C00098
First Posted: October 19, 2005    Key Record Dates
Last Update Posted: November 19, 2010
Last Verified: November 2010
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action