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Phase 3/Safety & Efficacy of Esomeprazole in Infants

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00468559
First received: April 30, 2007
Last updated: March 10, 2009
Last verified: March 2009
History of Changes
  Purpose

The purpose of this study is to look at the improvement of a once a day dose of esomeprazole for reducing the signs and symptoms of infants with gastroesophageal reflux disease (GERD). This research study consists of a screening, open-label, and double-blind phase. The screening phase ensures the patient eligibility. No study medication is dispensed during the screening phase. During the open-label phase, patients are administered esomeprazole 2.5mg, 5.0mg or 10.0mg based on his/her weight. During the double-blind phase, the patients are administered either his/her open-label dose or placebo. Double-blind means neither the physician, parent, or patient will know if patient is taking esomeprazole or placebo. The patient will have an equal chance of receiving esomeprazole or placebo.


Condition Intervention Phase
Gastroesophageal Reflux Disease (GERD)
 Drug: Esomeprazole
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Treatment-Withdrawal Study to Evaluate the Efficacy and Safety of Esomeprazole for the Treatment of Gastroesophageal Reflux (GERD) in Infants Aged 1 to 11 Months, Inclusive

Resource links provided by NLM:

MedlinePlus related topics: GERD
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Study Start Date: April 2007
Study Completion Date: June 2008
  Eligibility

Ages Eligible for Study:   1 Month to 11 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients' parents must sign the informed consent prior to the beginning of any study-related procedures (according to local regulations)
  • patients must have symptoms at study entry and have a clinical diagnosis of suspected GERD, symptomatic GERD, or GERD proven by a test called an endoscopy, a test using a long tube inserted in the body for diagnostic exams

Exclusion Criteria:

  • patients who have used a PPI (proton pump inhibitors; used to reduce the amount of acid in the stomach) within 7 days before enrollment in the open label treatment phase (Day 0)
  • patients with a history of acute life-threatening event
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00468559

  Show 25 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Marta Ilueca AstraZeneca
Study Director: Jennifer Heckman AstraZeneca
Study Director: Jill McGuinn AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00468559     History of Changes
Other Study ID Numbers: D9614C00096
Study First Received: April 30, 2007
Last Updated: March 10, 2009
Health Authority: United States: Food and Drug Administration
Germany: Federal Ministry of Food, Agriculture and Consumer Protection
Poland: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by AstraZeneca:
pediatrics
neonates

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Omeprazole
 Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013