Phase 3/Safety & Efficacy of Esomeprazole in Infants - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00468559

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

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

Study ID Numbers:	D9614C00096
Study First Received:	April 30, 2007
Last Updated:	March 10, 2009
ClinicalTrials.gov Identifier:	NCT00468559 History of Changes
Health Authority:	United States: Food and Drug Administration; Germany: Federal Ministry of Food, Agriculture and Consumer Protection; Poland: Ministry of Health; France: Afssaps - French Health Products Safety Agency

Keywords provided by AstraZeneca:

pediatrics
neonates

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gastrointestinal Agents
Omeprazole
Enzyme Inhibitors
Gastroesophageal Reflux
Pharmacologic Actions

Esophageal Motility Disorders
Deglutition Disorders
Digestive System Diseases
Therapeutic Uses
Anti-Ulcer Agents
Esophageal Diseases

ClinicalTrials.gov processed this record on February 08, 2010