Clinical trial NCT00427635: Efficacy and Safety of Esomeprazole Once Daily for the Treatment of GERD in Neonatal Patients
Official title: A Randomized, Double-blind, Placebo Controlled, Study to Evaluate the Efficacy and Safety of Esomeprazole Once Daily for the Treatment of Gastroesophageal Reflux Disease (GERD) in Neonatal Patients, Including Premature and up to 1 Month Corrected Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: GERD
Keywords: neonates
infants
GERD
reflux
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-01-29
Enrollment: 32
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring
timeFrame: Baseline and end of treatment (10-14 days)
Secondary outcomes:
measure: Change From Baseline in Normalized Number of GERD Events During Video and Cardiorespiratory Monitoring Associated With Acid Reflux
timeFrame: Baseline and end of treatment (10-14 days)
measure: Change From Baseline in Number of Reflux Episodes (Acid or Non-acid)
timeFrame: Baseline and end of treatment (10-14 days)
measure: Change From Baseline in Number of Acidic Reflux Episodes
timeFrame: Baseline and end of treatment (10-14 days)
measure: Change From Baseline in Number of Weakly Acidic Reflux Episodes
timeFrame: Baseline and end of treatment (10-14 days)
measure: Change From Baseline in Number of Non Acidic Reflux Episodes
timeFrame: Baseline and end of treatment (10-14 days)
measure: Change From Baseline in Number of Liquid Acidic Reflux Episodes
timeFrame: Baseline and end of treatment (10-14 days)
measure: Change From Baseline in Number of Mixed Gas/Liquid Acidic Reflux Episodes
timeFrame: Baseline and end of treatment (10-14 days)
measure: Change From Baseline in Mean Bolus Clearance Time
timeFrame: Baseline and end of treatment (10-14 days)
measure: Change From Baseline in Mean Acid Clearance Time
timeFrame: Baseline and end of treatment (10-14 days)
measure: Change From Baseline in Percentage Time With pH<4.0
timeFrame: Baseline and end of treatment (10-14 days)
measure: Change From Baseline in Percentage Time With pH Within 4.0-6.9
timeFrame: Baseline and end of treatment (10-14 days)
Other outcomes:
Locations:
city: North Adelaide
country: Australia
facility: Research Site
city: Aachen
country: Germany
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Marta Illueca, MD
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Per Lundborg, MD
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Kathryn Collison, MPH, MT(ASCP)
role: STUDY_DIRECTOR
References:
citation: Davidson G, Wenzl TG, Thomson M, Omari T, Barker P, Lundborg P, Illueca M. Efficacy and safety of once-daily esomeprazole for the treatment of gastroesophageal reflux disease in neonatal patients. J Pediatr. 2013 Sep;163(3):692-8.e1-2. doi: 10.1016/j.jpeds.2013.05.007. Epub 2013 Jun 22.