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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00427635
Recruitment Status : Completed
First Posted : January 29, 2007
Results First Posted : May 19, 2010
Last Update Posted : December 20, 2010
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE January 25, 2007
First Posted Date  ICMJE January 29, 2007
Results First Submitted Date  ICMJE April 19, 2010
Results First Posted Date  ICMJE May 19, 2010
Last Update Posted Date December 20, 2010
Study Start Date  ICMJE October 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2010)
Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring [ Time Frame: Baseline and end of treatment (10-14 days) ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 25, 2007)
Change from baseline in the number of occurrences of symptoms of GERD, as observed from video recording, and GERD-related signs detected from cardiorespiratory monitoring
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2010)
  • Change From Baseline in Normalized Number of GERD Events During Video and Cardiorespiratory Monitoring Associated With Acid Reflux [ Time Frame: Baseline and end of treatment (10-14 days) ]
    Event considered associated with reflux if start time of GERD sign/symptom is within 2 minutes of start time of acid reflux. 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.
  • Change From Baseline in Number of Reflux Episodes (Acid or Non-acid) [ Time Frame: Baseline and end of treatment (10-14 days) ]
    Number of reflux episodes based on 24-hour impedance monitoring data
  • Change From Baseline in Number of Acidic Reflux Episodes [ Time Frame: Baseline and end of treatment (10-14 days) ]
    Number of reflux episodes (pH<4.0) based on 24-hour impedance monitoring data
  • Change From Baseline in Number of Weakly Acidic Reflux Episodes [ Time Frame: Baseline and end of treatment (10-14 days) ]
    Number of reflux episodes (pH 4.0-6.9) based on 24-hour impedance monitoring data
  • Change From Baseline in Number of Non Acidic Reflux Episodes [ Time Frame: Baseline and end of treatment (10-14 days) ]
    Number of reflux episodes (pH>=7.0) based on 24-hour impedance monitoring data
  • Change From Baseline in Number of Liquid Acidic Reflux Episodes [ Time Frame: Baseline and end of treatment (10-14 days) ]
    Number of reflux episodes based on 24-hour impedance monitoring data
  • Change From Baseline in Number of Mixed Gas/Liquid Acidic Reflux Episodes [ Time Frame: Baseline and end of treatment (10-14 days) ]
    Number of reflux episodes based on 24-hour impedance monitoring data
  • Change From Baseline in Mean Bolus Clearance Time [ Time Frame: Baseline and end of treatment (10-14 days) ]
    Based on 24-hour impedance monitoring data
  • Change From Baseline in Mean Acid Clearance Time [ Time Frame: Baseline and end of treatment (10-14 days) ]
    Based on 24-hour impedance monitoring data
  • Change From Baseline in Percentage Time With pH<4.0 [ Time Frame: Baseline and end of treatment (10-14 days) ]
    Percentage time with pH<4 during 24-hour pH monitoring
  • Change From Baseline in Percentage Time With pH Within 4.0-6.9 [ Time Frame: Baseline and end of treatment (10-14 days) ]
    Percentage time with pH 4.0-6.9 during 24-hour pH monitoring
Original Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2007)
Change from baseline in symptomatic reflux episodes detected by pH/impedance monitoring, number of GERD-related signs of oxygen desaturation, apnea, and bradycardia, volume and frequency of vomiting episodes, volume, frequency and duration of feeding
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Esomeprazole Once Daily for the Treatment of GERD in Neonatal Patients
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE GERD
Intervention  ICMJE Drug: Esomeprazole
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 19, 2010)
32
Original Enrollment  ICMJE
 (submitted: January 25, 2007)
90
Actual Study Completion Date  ICMJE April 2009
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 1 Month   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Germany,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00427635
Other Study ID Numbers  ICMJE D9614C00004
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Marta Illueca, MD AstraZeneca
Study Director: Per Lundborg, MD AstraZeneca
Study Director: Kathryn Collison, MPH, MT(ASCP) AstraZeneca
PRS Account AstraZeneca
Verification Date December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP