Phase 3/Safety & Efficacy of Esomeprazole in Infants

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Gastroesophageal Reflux Disease (GERD)

Treatments: Drug: Open Label Run In Esomeprazole; Drug: Double Blind Placebo; Drug: Double Blind Esomeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00468559

D9614C00096

Details and patient eligibility

About

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 treatment withdrawal 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.

Enrollment: 98 patients

Sex: All

Ages: 1 to 11 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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98 participants in 3 patient groups, including a placebo group

Open Label Esomeprazole

Experimental group

Description:

This is an open label, run-in phase. All patients received Esomeprazole.

Treatment:

Drug: Open Label Run In Esomeprazole

Double Blind Esomeprazole

Experimental group

Description:

This is the double blind withdrawal phase. Patients are randomized to active drug or placebo.

Treatment:

Drug: Double Blind Esomeprazole

Double Blind Placebo

Placebo Comparator group

Description:

This is the double blind withdrawal phase. Patients are randomized to active drug or placebo.

Treatment:

Drug: Double Blind Placebo