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Phase 3/Safety & Efficacy of Esomeprazole in Infants

NCT00468559 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2014-06-02

Study results available
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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 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.

Conditions

  • Gastroesophageal Reflux Disease (GERD)

Interventions

DRUG

Open Label Run In Esomeprazole

Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg)

DRUG

Double Blind Esomeprazole

Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg)

DRUG

Double Blind Placebo

Double Blind Placebo

Sponsors & Collaborators

Principal Investigators

  • Marta Ilueca · AstraZeneca

  • Jennifer Heckman · AstraZeneca

  • Jill McGuinn · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
11 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • United States
  • France
  • Germany
  • Poland

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00468559 on ClinicalTrials.gov