NCT00427635

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2006

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2007

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 19, 2010

Completed
Last Updated

December 20, 2010

Status Verified

December 1, 2010

First QC Date

January 25, 2007

Results QC Date

April 19, 2010

Last Update Submit

December 2, 2010

Conditions

GERD

Keywords

neonatesinfantsGERDreflux

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring

    The number of events are normalized prior to summary to correspond to a complete 8-hour monitoring period. Only patients with data at both baseline and final assessment are included.

    Baseline and end of treatment (10-14 days)

Secondary Outcomes (11)

  • Change From Baseline in Normalized Number of GERD Events During Video and Cardiorespiratory Monitoring Associated With Acid Reflux

    Baseline and end of treatment (10-14 days)

  • Change From Baseline in Number of Reflux Episodes (Acid or Non-acid)

    Baseline and end of treatment (10-14 days)

  • Change From Baseline in Number of Acidic Reflux Episodes

    Baseline and end of treatment (10-14 days)

  • Change From Baseline in Number of Weakly Acidic Reflux Episodes

    Baseline and end of treatment (10-14 days)

  • Change From Baseline in Number of Non Acidic Reflux Episodes

    Baseline and end of treatment (10-14 days)

  • +6 more secondary outcomes

Interventions

EsomeprazoleDRUG

Eligibility Criteria

AgeUp to 1 Month
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

North Adelaide, Australia

Location

Research Site

Aachen, Germany

Location

Research Site

Sheffield, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 23800403DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com

Study Officials

  • Marta Illueca, MD

    AstraZeneca

    STUDY DIRECTOR

  • Per Lundborg, MD

    AstraZeneca

    STUDY DIRECTOR

  • Kathryn Collison, MPH, MT(ASCP)

    AstraZeneca

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 25, 2007

First Posted

January 29, 2007

Study Start

October 1, 2006

Study Completion

April 1, 2009

Last Updated

December 20, 2010

Results First Posted

May 19, 2010

Record last verified: 2010-12

Locations

GB(1)DE(1)AU(1)