Phase 3 Completed N=52 Randomized Double-blind Treatment

Efficacy and Safety of Esomeprazole Once Daily for the Treatment of GERD in Neonatal Patients

GERD

Source: ClinicalTrials.gov NCT00427635 ↗

Enrolled (actual)

Serious AEs

23.1%

Results posted

May 2010

Primary outcomePrimary: Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring — -28.01; -24.79 Mean Number of Events

Summary

The purpose of this study is to assess the difference between esomeprazole and placebo in the treatment of signs and symptoms as observed by 8-hour video and cardiorespiratory monitoring in neonatal patients.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring	-28.01; -24.79	—
SECONDARY Change From Baseline in Normalized Number of GERD Events During Video and Cardiorespiratory Monitoring Associated With Acid Reflux	-21.79; -13.49	—
SECONDARY Change From Baseline in Number of Reflux Episodes (Acid or Non-acid)	-14.55; 6.27	—
SECONDARY Change From Baseline in Number of Acidic Reflux Episodes	-37.75; 2.36	—
SECONDARY Change From Baseline in Number of Weakly Acidic Reflux Episodes	22.60; 3.59	—
SECONDARY Change From Baseline in Number of Non Acidic Reflux Episodes	0.60; 0.32	—
SECONDARY Change From Baseline in Number of Liquid Acidic Reflux Episodes	-19.00; 3.05	—
SECONDARY Change From Baseline in Number of Mixed Gas/Liquid Acidic Reflux Episodes	4.45; 3.27	—
SECONDARY Change From Baseline in Mean Bolus Clearance Time	-0.29; -4.05	—
SECONDARY Change From Baseline in Mean Acid Clearance Time	5.93; -6.36	—
SECONDARY Change From Baseline in Percentage Time With pH<4.0	-10.73; 2.24	—
SECONDARY Change From Baseline in Percentage Time With pH Within 4.0-6.9	9.84; -2.60	—

Eligibility Criteria

Inclusion Criteria

Full-term or gestational age >/= 28 to 44 weeks
In-patient in Neonatal Intensive Care Unit, special care nursery, or equivalent
Patient must be on a stable mode of feeding or with minimal variations for at least 2 days prior to randomization

Exclusion Criteria

Patients with a need for resectional or reconstructive surgery of the gastrointestinal tract
Patients with any condition that may require surgery during the course of the study
Patients with acute respiratory distress within 72 hours prior to enrollment

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00427635). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.