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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition GERD
Intervention Drug: Esomeprazole
Enrollment 32
Recruitment Details Participants either full term or those with a gestational age or post-conceptual age ³28 to 44 weeks, and who were inpatients suspected of having the following clinical findings: any 2 (either individually or in any combination) of (1) apnea +/- bradycardia +/- oxygen desaturations, (2) vomiting/gagging, (3) irritability/pain at least every second
Pre-assignment Details  
Arm/Group Title Esomeprazole Placebo
Hide Arm/Group Description Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling. Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
Period Title: Treatment Phase
Started 26 [1] 26 [1]
Completed 25 [2] 26 [3]
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
[1]
Randomised
[2]
ITT population. One voluntary discontinuation by parent/guardian
[3]
ITT population
Period Title: Study Completion to Safety Follow-up
Started 25 26
Completed 25 25 [1]
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
[1]
One participant lost to follow-up
Arm/Group Title Esomeprazole Placebo Total
Hide Arm/Group Description Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling. Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling. Total of all reporting groups
Overall Number of Baseline Participants 26 26 52
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 26 participants 26 participants 52 participants
46.5  (30.3) 46.5  (31.2) 46.5  (30.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 26 participants 52 participants
Female
15
  57.7%
15
  57.7%
30
  57.7%
Male
11
  42.3%
11
  42.3%
22
  42.3%
1.Primary Outcome
Title Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring
Hide Description 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.
Time Frame Baseline and end of treatment (10-14 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole Placebo
Hide Arm/Group Description:
Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
Overall Number of Participants Analyzed 25 26
Mean (Standard Deviation)
Unit of Measure: Mean Number of Events
-28.01  (77.70) -24.79  (44.25)
2.Secondary Outcome
Title Change From Baseline in Normalized Number of GERD Events During Video and Cardiorespiratory Monitoring Associated With Acid Reflux
Hide Description 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.
Time Frame Baseline and end of treatment (10-14 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole Placebo
Hide Arm/Group Description:
Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
Overall Number of Participants Analyzed 25 25
Mean (Standard Deviation)
Unit of Measure: Mean Number of Events
-21.79  (40.37) -13.49  (32.76)
3.Secondary Outcome
Title Change From Baseline in Number of Reflux Episodes (Acid or Non-acid)
Hide Description Number of reflux episodes based on 24-hour impedance monitoring data
Time Frame Baseline and end of treatment (10-14 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole Placebo
Hide Arm/Group Description:
Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
Overall Number of Participants Analyzed 20 22
Mean (Standard Deviation)
Unit of Measure: Mean Number of Episodes
-14.55  (49.58) 6.27  (28.50)
4.Secondary Outcome
Title Change From Baseline in Number of Acidic Reflux Episodes
Hide Description Number of reflux episodes (pH<4.0) based on 24-hour impedance monitoring data
Time Frame Baseline and end of treatment (10-14 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole Placebo
Hide Arm/Group Description:
Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
Overall Number of Participants Analyzed 20 22
Mean (Standard Deviation)
Unit of Measure: Mean Number of Episodes
-37.75  (32.38) 2.36  (18.35)
5.Secondary Outcome
Title Change From Baseline in Number of Weakly Acidic Reflux Episodes
Hide Description Number of reflux episodes (pH 4.0-6.9) based on 24-hour impedance monitoring data
Time Frame Baseline and end of treatment (10-14 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole Placebo
Hide Arm/Group Description:
Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
Overall Number of Participants Analyzed 20 22
Mean (Standard Deviation)
Unit of Measure: Mean Number of Episodes
22.60  (45.17) 3.59  (21.60)
6.Secondary Outcome
Title Change From Baseline in Number of Non Acidic Reflux Episodes
Hide Description Number of reflux episodes (pH>=7.0) based on 24-hour impedance monitoring data
Time Frame Baseline and end of treatment (10-14 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole Placebo
Hide Arm/Group Description:
Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
Overall Number of Participants Analyzed 20 22
Mean (Standard Deviation)
Unit of Measure: Mean Number of Episodes
0.60  (1.14) 0.32  (0.99)
7.Secondary Outcome
Title Change From Baseline in Number of Liquid Acidic Reflux Episodes
Hide Description Number of reflux episodes based on 24-hour impedance monitoring data
Time Frame Baseline and end of treatment (10-14 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole Placebo
Hide Arm/Group Description:
Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
Overall Number of Participants Analyzed 20 22
Mean (Standard Deviation)
Unit of Measure: Mean Number of Episodes
-19.00  (52.03) 3.05  (31.19)
8.Secondary Outcome
Title Change From Baseline in Number of Mixed Gas/Liquid Acidic Reflux Episodes
Hide Description Number of reflux episodes based on 24-hour impedance monitoring data
Time Frame Baseline and end of treatment (10-14 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole Placebo
Hide Arm/Group Description:
Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
Overall Number of Participants Analyzed 20 22
Mean (Standard Deviation)
Unit of Measure: Mean Number of Episodes
4.45  (17.44) 3.27  (13.84)
9.Secondary Outcome
Title Change From Baseline in Mean Bolus Clearance Time
Hide Description Based on 24-hour impedance monitoring data
Time Frame Baseline and end of treatment (10-14 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole Placebo
Hide Arm/Group Description:
Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
Overall Number of Participants Analyzed 20 22
Mean (Standard Deviation)
Unit of Measure: Seconds
-0.29  (24.56) -4.05  (25.61)
10.Secondary Outcome
Title Change From Baseline in Mean Acid Clearance Time
Hide Description Based on 24-hour impedance monitoring data
Time Frame Baseline and end of treatment (10-14 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole Placebo
Hide Arm/Group Description:
Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
Overall Number of Participants Analyzed 20 22
Mean (Standard Deviation)
Unit of Measure: Seconds
5.93  (64.32) -6.36  (45.38)
11.Secondary Outcome
Title Change From Baseline in Percentage Time With pH<4.0
Hide Description Percentage time with pH<4 during 24-hour pH monitoring
Time Frame Baseline and end of treatment (10-14 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole Placebo
Hide Arm/Group Description:
Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
Overall Number of Participants Analyzed 20 22
Mean (Standard Deviation)
Unit of Measure: Percentage
-10.73  (12.63) 2.24  (12.38)
12.Secondary Outcome
Title Change From Baseline in Percentage Time With pH Within 4.0-6.9
Hide Description Percentage time with pH 4.0-6.9 during 24-hour pH monitoring
Time Frame Baseline and end of treatment (10-14 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole Placebo
Hide Arm/Group Description:
Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
Overall Number of Participants Analyzed 20 22
Mean (Standard Deviation)
Unit of Measure: Percentage
9.84  (12.64) -2.60  (12.18)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Esomeprazole Placebo
Hide Arm/Group Description Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling. Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
All-Cause Mortality
Esomeprazole Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Esomeprazole Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   3/7 (42.86%) 
Cardiac disorders     
Bradycardia Neonatal  1  0/6 (0.00%)  1/7 (14.29%) 
Cyanosis  1  0/6 (0.00%)  1/7 (14.29%) 
Injury, poisoning and procedural complications     
Inappropriate Device Signal Detection  1  0/6 (0.00%)  1/7 (14.29%) 
Respiratory, thoracic and mediastinal disorders     
Infantile Apnoeic Attack  1  0/6 (0.00%)  1/7 (14.29%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Esomeprazole Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   6/6 (100.00%)   7/7 (100.00%) 
Blood and lymphatic system disorders     
Anaemia Neonatal  1  1/6 (16.67%)  1/7 (14.29%) 
Cardiac disorders     
Cyanosis  1  0/6 (0.00%)  1/7 (14.29%) 
Ear and labyrinth disorders     
Deafness Neurosensory  1  1/6 (16.67%)  0/7 (0.00%) 
Eye disorders     
Conjunctivitis  1  1/6 (16.67%)  0/7 (0.00%) 
Retinopathy Of Prematurity  1  1/6 (16.67%)  0/7 (0.00%) 
Gastrointestinal disorders     
Constipation  1  0/6 (0.00%)  2/7 (28.57%) 
Flatulence  1  1/6 (16.67%)  1/7 (14.29%) 
Gastrooesophageal Reflux Disease  1  1/6 (16.67%)  0/7 (0.00%) 
Diarrhoea  1  0/6 (0.00%)  1/7 (14.29%) 
General disorders     
Oedema Peripheral  1  1/6 (16.67%)  0/7 (0.00%) 
Infections and infestations     
Neonatal Infection  1  1/6 (16.67%)  0/7 (0.00%) 
Bronchiolitis  1  0/6 (0.00%)  1/7 (14.29%) 
Nasopharyngitis  1  0/6 (0.00%)  1/7 (14.29%) 
Urinary Tract Infection Neonatal  1  0/6 (0.00%)  1/7 (14.29%) 
Oxygen Saturation Decreased  1  2/6 (33.33%)  1/7 (14.29%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gerard Lynch
Organization: AstraZeneca
EMail: aztrial_results_posting@astrazeneca.com
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00427635    
Other Study ID Numbers: D9614C00004
First Submitted: January 25, 2007
First Posted: January 29, 2007
Results First Submitted: April 19, 2010
Results First Posted: May 19, 2010
Last Update Posted: December 20, 2010