Phase 3/Safety & Efficacy of Esomeprazole in Infants
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroesophageal Reflux Disease (GERD)
Intervention: Esomeprazole (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Marta Ilueca, Study Director, Affiliation: AstraZeneca
Jennifer Heckman, Study Director, Affiliation: AstraZeneca
Jill McGuinn, Study Director, Affiliation: AstraZeneca
Overall contact:
AstraZeneca Clinical Study, Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 1 Month.
Maximum age: 11 Months.
Gender(s): Both.
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
Locations and Contacts
AstraZeneca Clinical Study, Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com
Research Site, Lille Cedex, France; Not yet recruiting
Research Site, Paris, France; Not yet recruiting
Research Site, Potsdam, Germany; Not yet recruiting
Research Site, Nurberg, Germany; Not yet recruiting
Research Site, Bochum, Germany; Not yet recruiting
Research Site, Wuppental, Germany; Not yet recruiting
Research Site, Greifswald, Germany; Not yet recruiting
Research Site, Krakow, Poland; Not yet recruiting
Research Site, Wroclaw, Poland; Not yet recruiting
Research Site, Bialystok, Poland; Not yet recruiting
Research Site, Warszawa, Poland; Not yet recruiting
Research Site, Phoenix, Arizona, United States; Not yet recruiting
Research Site, Atlanta, Georgia, United States; Not yet recruiting
Research Site, Park Ridge, Illinois, United States; Recruiting
Research Site, Louisville, Kentucky, United States; Not yet recruiting
Research Site, Marrero, Louisiana, United States; Not yet recruiting
Research Site, Newton, Massachusetts, United States; Not yet recruiting
Research site, Southfield, Michigan, United States; Not yet recruiting
Research Site, Las Vegas, Nevada, United States; Not yet recruiting
Research Site, Brooklyn, New York, United States; Not yet recruiting
Research Site, New York, New York, United States; Not yet recruiting
Research Site, Dayton, Ohio, United States; Not yet recruiting
Research Site, Akron, Ohio, United States; Not yet recruiting
Research Site, Chattanooga, Tennessee, United States; Recruiting
Research Site, Roanoke, Virginia, United States; Not yet recruiting
Additional Information
Starting date: April 2007
Last updated: September 10, 2007
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