Trial Outcomes & Findings for Efficacy and Safety of Esomeprazole Once Daily for the Treatment of GERD in Neonatal Patients (NCT NCT00427635)
NCT ID: NCT00427635
Last Updated: 2010-12-20
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
32 participants
Primary outcome timeframe
Baseline and end of treatment (10-14 days)
Results posted on
2010-12-20
Participant Flow
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
Participant milestones
| Measure |
Esomeprazole
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
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.
|
|---|---|---|
|
Treatment Phase
STARTED
|
26
|
26
|
|
Treatment Phase
COMPLETED
|
25
|
26
|
|
Treatment Phase
NOT COMPLETED
|
1
|
0
|
|
Study Completion to Safety Follow-up
STARTED
|
25
|
26
|
|
Study Completion to Safety Follow-up
COMPLETED
|
25
|
25
|
|
Study Completion to Safety Follow-up
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Esomeprazole
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
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.
|
|---|---|---|
|
Treatment Phase
Withdrawal by Subject
|
1
|
0
|
|
Study Completion to Safety Follow-up
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Esomeprazole Once Daily for the Treatment of GERD in Neonatal Patients
Baseline characteristics by cohort
| Measure |
Esomeprazole
n=26 Participants
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
n=26 Participants
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
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
46.5 Days
STANDARD_DEVIATION 30.3 • n=5 Participants
|
46.5 Days
STANDARD_DEVIATION 31.2 • n=7 Participants
|
46.5 Days
STANDARD_DEVIATION 30.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Esomeprazole
n=25 Participants
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
n=26 Participants
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.
|
|---|---|---|
|
Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring
|
-28.01 Mean Number of Events
Standard Deviation 77.70
|
-24.79 Mean Number of Events
Standard Deviation 44.25
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Esomeprazole
n=25 Participants
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
n=25 Participants
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.
|
|---|---|---|
|
Change From Baseline in Normalized Number of GERD Events During Video and Cardiorespiratory Monitoring Associated With Acid Reflux
|
-21.79 Mean Number of Events
Standard Deviation 40.37
|
-13.49 Mean Number of Events
Standard Deviation 32.76
|
SECONDARY outcome
Timeframe: Baseline and end of treatment (10-14 days)Number of reflux episodes based on 24-hour impedance monitoring data
Outcome measures
| Measure |
Esomeprazole
n=20 Participants
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
n=22 Participants
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.
|
|---|---|---|
|
Change From Baseline in Number of Reflux Episodes (Acid or Non-acid)
|
-14.55 Mean Number of Episodes
Standard Deviation 49.58
|
6.27 Mean Number of Episodes
Standard Deviation 28.50
|
SECONDARY outcome
Timeframe: Baseline and end of treatment (10-14 days)Number of reflux episodes (pH\<4.0) based on 24-hour impedance monitoring data
Outcome measures
| Measure |
Esomeprazole
n=20 Participants
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
n=22 Participants
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.
|
|---|---|---|
|
Change From Baseline in Number of Acidic Reflux Episodes
|
-37.75 Mean Number of Episodes
Standard Deviation 32.38
|
2.36 Mean Number of Episodes
Standard Deviation 18.35
|
SECONDARY outcome
Timeframe: Baseline and end of treatment (10-14 days)Number of reflux episodes (pH 4.0-6.9) based on 24-hour impedance monitoring data
Outcome measures
| Measure |
Esomeprazole
n=20 Participants
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
n=22 Participants
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.
|
|---|---|---|
|
Change From Baseline in Number of Weakly Acidic Reflux Episodes
|
22.60 Mean Number of Episodes
Standard Deviation 45.17
|
3.59 Mean Number of Episodes
Standard Deviation 21.60
|
SECONDARY outcome
Timeframe: Baseline and end of treatment (10-14 days)Number of reflux episodes (pH\>=7.0) based on 24-hour impedance monitoring data
Outcome measures
| Measure |
Esomeprazole
n=20 Participants
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
n=22 Participants
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.
|
|---|---|---|
|
Change From Baseline in Number of Non Acidic Reflux Episodes
|
0.60 Mean Number of Episodes
Standard Deviation 1.14
|
0.32 Mean Number of Episodes
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: Baseline and end of treatment (10-14 days)Number of reflux episodes based on 24-hour impedance monitoring data
Outcome measures
| Measure |
Esomeprazole
n=20 Participants
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
n=22 Participants
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.
|
|---|---|---|
|
Change From Baseline in Number of Liquid Acidic Reflux Episodes
|
-19.00 Mean Number of Episodes
Standard Deviation 52.03
|
3.05 Mean Number of Episodes
Standard Deviation 31.19
|
SECONDARY outcome
Timeframe: Baseline and end of treatment (10-14 days)Number of reflux episodes based on 24-hour impedance monitoring data
Outcome measures
| Measure |
Esomeprazole
n=20 Participants
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
n=22 Participants
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.
|
|---|---|---|
|
Change From Baseline in Number of Mixed Gas/Liquid Acidic Reflux Episodes
|
4.45 Mean Number of Episodes
Standard Deviation 17.44
|
3.27 Mean Number of Episodes
Standard Deviation 13.84
|
SECONDARY outcome
Timeframe: Baseline and end of treatment (10-14 days)Based on 24-hour impedance monitoring data
Outcome measures
| Measure |
Esomeprazole
n=20 Participants
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
n=22 Participants
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.
|
|---|---|---|
|
Change From Baseline in Mean Bolus Clearance Time
|
-0.29 Seconds
Standard Deviation 24.56
|
-4.05 Seconds
Standard Deviation 25.61
|
SECONDARY outcome
Timeframe: Baseline and end of treatment (10-14 days)Based on 24-hour impedance monitoring data
Outcome measures
| Measure |
Esomeprazole
n=20 Participants
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
n=22 Participants
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.
|
|---|---|---|
|
Change From Baseline in Mean Acid Clearance Time
|
5.93 Seconds
Standard Deviation 64.32
|
-6.36 Seconds
Standard Deviation 45.38
|
SECONDARY outcome
Timeframe: Baseline and end of treatment (10-14 days)Percentage time with pH\<4 during 24-hour pH monitoring
Outcome measures
| Measure |
Esomeprazole
n=20 Participants
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
n=22 Participants
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.
|
|---|---|---|
|
Change From Baseline in Percentage Time With pH<4.0
|
-10.73 Percentage
Standard Deviation 12.63
|
2.24 Percentage
Standard Deviation 12.38
|
SECONDARY outcome
Timeframe: Baseline and end of treatment (10-14 days)Percentage time with pH 4.0-6.9 during 24-hour pH monitoring
Outcome measures
| Measure |
Esomeprazole
n=20 Participants
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
n=22 Participants
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.
|
|---|---|---|
|
Change From Baseline in Percentage Time With pH Within 4.0-6.9
|
9.84 Percentage
Standard Deviation 12.64
|
-2.60 Percentage
Standard Deviation 12.18
|
Adverse Events
Esomeprazole
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Esomeprazole
n=6 participants at risk
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
n=7 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Bradycardia Neonatal
|
0.00%
0/6
|
14.3%
1/7
|
|
Cardiac disorders
Cyanosis
|
0.00%
0/6
|
14.3%
1/7
|
|
Injury, poisoning and procedural complications
Inappropriate Device Signal Detection
|
0.00%
0/6
|
14.3%
1/7
|
|
Respiratory, thoracic and mediastinal disorders
Infantile Apnoeic Attack
|
0.00%
0/6
|
14.3%
1/7
|
Other adverse events
| Measure |
Esomeprazole
n=6 participants at risk
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
n=7 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Flatulence
|
16.7%
1/6
|
14.3%
1/7
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
16.7%
1/6
|
0.00%
0/7
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6
|
14.3%
1/7
|
|
General disorders
Oedema Peripheral
|
16.7%
1/6
|
0.00%
0/7
|
|
Infections and infestations
Neonatal Infection
|
16.7%
1/6
|
0.00%
0/7
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/6
|
14.3%
1/7
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6
|
14.3%
1/7
|
|
Infections and infestations
Urinary Tract Infection Neonatal
|
0.00%
0/6
|
14.3%
1/7
|
|
Infections and infestations
Oxygen Saturation Decreased
|
33.3%
2/6
|
14.3%
1/7
|
|
Blood and lymphatic system disorders
Anaemia Neonatal
|
16.7%
1/6
|
14.3%
1/7
|
|
Cardiac disorders
Cyanosis
|
0.00%
0/6
|
14.3%
1/7
|
|
Ear and labyrinth disorders
Deafness Neurosensory
|
16.7%
1/6
|
0.00%
0/7
|
|
Eye disorders
Conjunctivitis
|
16.7%
1/6
|
0.00%
0/7
|
|
Eye disorders
Retinopathy Of Prematurity
|
16.7%
1/6
|
0.00%
0/7
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6
|
28.6%
2/7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60