Clinical Trial Results:
An Open Single-centre Study on the Pharmacokinetics and Pharmacodynamics of Esomeprazole After Once Daily Oral Administration for 7 Days in Preterm Infants and Neonates
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Summary
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EudraCT number |
2012-001160-29 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
10 Jan 2007
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Results information
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Results version number |
v1(current) |
This version publication date |
01 Feb 2017
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First version publication date |
13 Aug 2015
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
SH-NEC-0002
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
AstraZeneca R&D
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Sponsor organisation address |
Pepparedsled 1, Mölndal, Sweden,
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Public contact |
AZ Clinical Trial Transparency group, AstraZeneca R&D, ClinicalTrialTransparency@astrazeneca.com
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Scientific contact |
Per Lundborg, MD, PhD , AstraZeneca R&D Mölndal, 46 317761000,
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-000331-PIP01-08 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
10 Jan 2007
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
10 Jan 2007
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Global end of trial reached? |
Yes
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Global end of trial date |
10 Jan 2007
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective was to assess the pharmacokinetics of esomeprazole and its effect on intragastric pH in preterm infants and neonates.
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Protection of trial subjects |
The study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with ICH/Good Clinical Practice and applicable regulatory requirements and the AstraZeneca policy on Bioethics. Consideration has been given to the International Conference on Harmonisation (ICH) guideline CPMP/ICH/2711/99 (Note for clinical investigation of medicinal products in the pediatric population) when developing the study.The study was approved by the Independent Research Ethics Committee (IEC) of the Women’s and Children’s Hospital, 72 King William Road, North Adelaide, South Australia 5006
Since all subjects in this study were preterm infants or neonates, informed consent could not be obtained from the subjects themselves. Therefore, the principal investigator ensured that the parent(s) or guardian(s) was given full and adequate oral and written information about the nature, purpose, possible risks and benefits of the study. Parents/guardians were also notified that they were free to withdraw their child from participation in the study at any time. The parent(s)/guardian(s) was given the opportunity to ask questions, and was given time for consideration. The parent’s/guardian’s signed informed consent was obtained before any study specific procedure was conducted.
Subjects could be withdrawn from study treatment and assessments at any time at the discretion of the investigator.
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Background therapy |
The subject population comprised in- and outpatient preterm infants or neonates up to 1 month of age with symptoms of GERD and diagnosis confirmed by pH-monitoring. Medication considered necessary for the subject’s safety and well-being was to be given at the discretion of the investigator. Use of any pharmacological antireflux therapy within 72 hours prior to the diagnostic baseline pH impedance monitoring was exclusion criteria. Antacids (egMylanta) or food thickeners could be used +/- 1 hour of the administration of investigational product . | ||
Evidence for comparator |
No comparator group | ||
Actual start date of recruitment |
02 Jun 2004
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Australia: 26
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Worldwide total number of subjects |
26
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
19
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Newborns (0-27 days) |
7
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
First patient enrolled: 2 June 2004 Last patient completed: 8 March 2006 | ||||||||||
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Pre-assignment
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Screening details |
38 subjects were screened and 26 were eligible for the study. | ||||||||||
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Pre-assignment period milestones
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Number of subjects started |
26 | ||||||||||
Number of subjects completed |
26 | ||||||||||
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Period 1
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Period 1 title |
Treatment period (overall period)
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
Blinding implementation details |
Open label
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Arms
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Arm title
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Esomeprazole treatment | ||||||||||
Arm description |
Esomeprazole 0.5 mg/kg | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Esomeprazole
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Investigational medicinal product code |
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Other name |
NEXIUM
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
0.5 mg/kg od orally for 1 week
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Baseline characteristics reporting groups
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Reporting group title |
Treatment period
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Reporting group description |
Esomeprazole | ||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
All patients
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Subject analysis set type |
Intention-to-treat | ||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All patients entering treatment period
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End points reporting groups
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Reporting group title |
Esomeprazole treatment
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Reporting group description |
Esomeprazole 0.5 mg/kg | ||
Subject analysis set title |
All patients
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
All patients entering treatment period
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End point title |
AUCτ [1] | ||||||||
End point description |
Geometric mean of AUCτ (µmol*h/L) after 7 days of oral administration
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End point type |
Primary
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End point timeframe |
After 7 days of oral administration
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: There is no statistical analysis skpecifed, because it is a single arm study. Only discriptive statistics are presented. |
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End point title |
Css,max | ||||||||
End point description |
Geometric mean Css,max (µmol/L) after 7 days oral administration
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End point type |
Secondary
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End point timeframe |
After 7 days oral administration
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End point title |
Change from baseline in percentage of time with intragastric pH>4 | ||||||||
End point description |
Change from baseline in percentage of time (over 24 hours) with intragastric pH>4
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End point type |
Secondary
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End point timeframe |
from baseline to after 7 days oral administration
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
During 1 week treatment period and follow-up
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
9
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Reporting groups
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Reporting group title |
Esomeprazole
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Reporting group description |
esomeprazole 0.5 mg/kg | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Follow-up
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Reporting group description |
The period between time of administration of the investigational product Day 7 plus 24 hours, and the follow-up visit. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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20 Jan 2004 |
The mode of administration was changed from per oral by tube or syringe to per oral via a specially designed funnel pan |
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01 Jul 2004 |
An X-ray procedure was added at the pre-entry visit in order to confirm that the pH probe had been correctly positioned |
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09 Sep 2004 |
Due to slower recruitment than expected the recruitment period was prolonged |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
