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Trial record 11 of 49 for:    Zollinger-Ellison syndrome

A Phase I/III Study of D961H 10 mg and 20 mg in Japanese Paediatric Patients With Gastrointestinal Acid Related Diseases

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: NCT02153398
Recruitment Status : Completed
First Posted : June 3, 2014
Results First Posted : January 19, 2017
Last Update Posted : January 19, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Gastric Ulcer (GU)
Duodenal Ulcer (DU)
Anastomotic Ulcer (AU)
Non-erosive Reflux Esophagitis Disease (NERD)
Reflux Esophagitis (RE)
Zollinger-Ellison Syndrome
Interventions Drug: D961H sachet 10 mg
Drug: D961H capsule 10mg
Drug: D961H capsule 20 mg
Enrollment 55
Recruitment Details First subject enrolled on 24 June 2014 Last subject last visit on 04 April 2016. This study was conducted at a total of 20 sites in Japan.
Pre-assignment Details Out of 55 enrolled subjects, 50 subjects were registered and 5 subjects were not registered. The reason of no registration was 'Did not meet inclusion/exclusion criteria' (5 subjects).
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
Period Title: Overall Study
Started 10 10 10 10 10
Completed 9 10 9 9 10
Not Completed 1 0 1 1 0
Reason Not Completed
Withdrawal by Subject             1             0             0             0             0
Adverse Event             0             0             1             1             0
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5 Total
Hide Arm/Group Description D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg Total of all reporting groups
Overall Number of Baseline Participants 10 10 10 10 10 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 10 participants 10 participants 10 participants 50 participants
3.6  (2.2) 8.9  (0.7) 8.4  (1.8) 13.4  (0.7) 13.1  (0.9) 9.5  (3.9)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 10 participants 10 participants 50 participants
<= 3 years 5 0 0 0 0 5
4-5 years 2 0 0 0 0 2
6-7 years 3 0 4 0 0 7
8-9 years 0 8 3 0 0 11
10-11 years 0 2 3 0 0 5
12-14 years 0 0 0 10 10 20
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 10 participants 10 participants 50 participants
Female
5
  50.0%
6
  60.0%
2
  20.0%
7
  70.0%
6
  60.0%
26
  52.0%
Male
5
  50.0%
4
  40.0%
8
  80.0%
3
  30.0%
4
  40.0%
24
  48.0%
1.Primary Outcome
Title Disappearance of Heartburn at Week 8 by Patient Diaries
Hide Description The disappearance of heartburn was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of heartburn were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had heartburn at pre-dose in patient diary and obtained available diary data at Week 8.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:
D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
Overall Number of Participants Analyzed 2 3 1 1 4
Measure Type: Number
Unit of Measure: Participants
2 0 0 1 3
2.Primary Outcome
Title Disappearance of Epigastric Pain at Week 8 by Patient Diaries
Hide Description The disappearance of epigastric pain was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of epigastric pain were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had epigastric pain at pre-dose in patient diary and obtained available diary data at Week 8.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:
D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
Overall Number of Participants Analyzed 2 6 5 4 7
Measure Type: Number
Unit of Measure: Participants
2 3 5 1 3
3.Primary Outcome
Title Disappearance of Upper Abdominal Discomfort at Week 8 by Patient Diaries
Hide Description The disappearance of upper abdominal discomfort was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of upper abdominal discomfort were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had upper abdominal discomfort at pre-dose in patient diary and obtained available diary data at Week 8.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:
D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
Overall Number of Participants Analyzed 3 6 4 4 6
Measure Type: Number
Unit of Measure: Participants
3 2 4 2 2
4.Primary Outcome
Title Disappearance of Regurgitation at Week 8 by Patient Diaries
Hide Description The disappearance of regurgitation was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of regurgitation were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had regurgitation at pre-dose in patient diary and obtained available diary data at Week 8.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:
D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
Overall Number of Participants Analyzed 4 3 5 3 4
Measure Type: Number
Unit of Measure: Participants
3 2 3 2 4
5.Primary Outcome
Title Aggravation of Heartburn at Week 8 by Patient Diaries
Hide Description The aggravation of heartburn was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of heartburn were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had no heartburn at pre-dose in patient diary and obtained available diary data at Week 8.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:
D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
Overall Number of Participants Analyzed 7 7 8 8 6
Measure Type: Number
Unit of Measure: participants
0 0 0 0 0
6.Primary Outcome
Title Aggravation of Epigastric Pain at Week 8 by Patient Diaries
Hide Description The aggravation of epigastric pain was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of epigastric pain were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had no epigastric pain at pre-dose in patient diary and obtained available diary data at Week 8.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:
D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
Overall Number of Participants Analyzed 7 4 4 5 3
Measure Type: Number
Unit of Measure: participants
0 0 1 1 1
7.Primary Outcome
Title Aggravation of Upper Abdominal Discomfort at Week 8 by Patient Diaries
Hide Description The aggravation of upper abdominal discomfort was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of upper abdominal discomfort were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had no upper abdominal discomfort at pre-dose in patient diary and obtained available diary data at Week 8.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:
D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
Overall Number of Participants Analyzed 6 4 5 5 4
Measure Type: Number
Unit of Measure: participants
0 0 2 1 0
8.Primary Outcome
Title Aggravation of Regurgitation at Week 8 by Patient Diaries
Hide Description The aggravation of regurgitation was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of regurgitation were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had no regurgitation at pre-dose in patient diary and obtained available diary data at Week 8.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:
D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
Overall Number of Participants Analyzed 5 7 4 6 6
Measure Type: Number
Unit of Measure: participants
2 0 1 0 0
9.Primary Outcome
Title Disappearance of Heartburn at Week 8 by Investigators
Hide Description The investigators assessed the presence/absence and the intensity of heartburn at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized disappearance of heartburn were defined as those who had a heartburn at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had a heartburn at pre-dose and were evaluated the symptom at Week 8 by investigators.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:
D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
Overall Number of Participants Analyzed 2 2 0 2 3
Measure Type: Number
Unit of Measure: Participants
2 1 2 2
10.Primary Outcome
Title Disappearance of Epigastric Pain at Week 8 by Investigators
Hide Description The investigators assessed the presence/absence and the intensity of epigastric pain at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized disappearance of epigastric pain were defined as those who had an epigastric pain at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had an epigastric pain at pre-dose and were evaluated the symptom at Week 8 by investigators.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:
D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
Overall Number of Participants Analyzed 2 6 4 7 9
Measure Type: Number
Unit of Measure: Participants
2 5 4 2 6
11.Primary Outcome
Title Disappearance of Upper Abdominal Discomfort at Week 8 by Investigators
Hide Description The investigators assessed the presence/absence and the intensity of upper abdominal discomfort at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized disappearance of upper abdominal discomfort were defined as those who had an upper abdominal discomfort at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had an upper abdominal discomfort at pre-dose and were evaluated the symptom at Week 8 by investigators.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:
D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
Overall Number of Participants Analyzed 3 6 5 7 6
Measure Type: Number
Unit of Measure: Participants
3 5 4 4 3
12.Primary Outcome
Title Disappearance of Regurgitation at Week 8 by Investigators
Hide Description The investigators assessed the presence/absence and the intensity of regurgitation at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized disappearance of regurgitation were defined as those who had a regurgitation at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had a regurgitation at pre-dose and were evaluated the symptom at Week 8 by investigators.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:
D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
Overall Number of Participants Analyzed 4 1 5 1 3
Measure Type: Number
Unit of Measure: Participants
3 0 3 1 3
13.Primary Outcome
Title Aggravation of Heartburn at Week 8 by Investigators
Hide Description The investigators assessed the presence/absence and the intensity of heartburn at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized aggravation of heartburn were defined as those who had no heartburn at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had no heartburn at pre-dose and were evaluated the symptom at Week 8 by investigators.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:
D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
Overall Number of Participants Analyzed 7 8 9 7 7
Measure Type: Number
Unit of Measure: Participants
0 0 0 1 0
14.Primary Outcome
Title Aggravation of Epigastric Pain at Week 8 by Investigators
Hide Description The investigators assessed the presence/absence and the intensity of epigastric pain at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized aggravation of epigastric pain were defined as those who had no epigastric pain at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had no epigastric pain at pre-dose and were evaluated the symptom at Week 8 by investigators.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:
D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
Overall Number of Participants Analyzed 7 4 5 2 1
Measure Type: Number
Unit of Measure: Participants
0 0 0 0 0
15.Primary Outcome
Title Aggravation of Upper Abdominal Discomfort at Week 8 by Investigators
Hide Description The investigators assessed the presence/absence and the intensity of upper abdominal discomfort at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized aggravation of upper abdominal discomfort were defined as those who had no upper abdominal discomfort at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had no upper abdominal discomfort at pre-dose and were evaluated the symptom at Week 8 by investigators.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:
D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
Overall Number of Participants Analyzed 6 4 4 2 4
Measure Type: Number
Unit of Measure: Participants
0 0 0 1 0
16.Primary Outcome
Title Aggravation of Regurgitation at Week 8 by Investigators
Hide Description The investigators assessed the presence/absence and the intensity of regurgitation at baseline and Week 8 based on questioning the patients or patients’ guardians and the patient diary. Patients who recognized aggravation of regurgitation were defined as those who had no regurgitation at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had no regurgitation at pre-dose and were evaluated the symptom at Week 8 by investigators.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:
D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
Overall Number of Participants Analyzed 5 9 4 8 7
Measure Type: Number
Unit of Measure: Participants
0 0 1 0 1
17.Secondary Outcome
Title Area Under the Plasma Concentration-time Curve During a Dosing Interval (AUCtau) of Esomeprazole After at Least 5 Days of Repeated Dose
Hide Description [Not Specified]
Time Frame 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the pharmacokinetics (PK).
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:
D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
Overall Number of Participants Analyzed 7 9 10 9 10
Mean (Standard Deviation)
Unit of Measure: μmol*h/L
7.04  (3.05) 3.52  (2.35) 11.05  (5.11) 2.38  (1.74) 5.82  (1.85)
18.Secondary Outcome
Title AUC From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of Esomeprazole After at Least 5 Days of Repeated Dose
Hide Description [Not Specified]
Time Frame 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:
D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
Overall Number of Participants Analyzed 9 10 10 9 10
Mean (Standard Deviation)
Unit of Measure: μmol*h/L
5.53  (3.69) 3.09  (2.34) 10.41  (4.55) 1.99  (1.30) 5.45  (1.78)
19.Secondary Outcome
Title Maximum Plasma Concentration (Cmax) of Esomeprazole After at Least 5 Days of Repeated Dose
Hide Description [Not Specified]
Time Frame 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:
D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
Overall Number of Participants Analyzed 9 10 10 9 10
Mean (Standard Deviation)
Unit of Measure: μmol/L
3.42  (2.09) 2.09  (1.53) 5.91  (2.19) 1.09  (0.57) 3.13  (1.36)
20.Secondary Outcome
Title Time to Reach Maximum Plasma Concentration (Tmax) of Esomeprazole After at Least 5 Days of Repeated Dose
Hide Description [Not Specified]
Time Frame 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:
D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
Overall Number of Participants Analyzed 9 10 10 9 10
Median (Full Range)
Unit of Measure: hour
1.58
(1.03 to 5.92)
1.52
(0.92 to 6.00)
1.47
(0.93 to 1.52)
1.57
(0.93 to 2.95)
1.75
(0.95 to 3.00)
21.Secondary Outcome
Title Elimination Half-life (t1/2) of Esomeprazole After at Least 5 Days of Repeated Dose
Hide Description [Not Specified]
Time Frame 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:
D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
Overall Number of Participants Analyzed 7 9 10 9 10
Mean (Standard Deviation)
Unit of Measure: hour
0.80  (0.18) 0.97  (0.55) 1.08  (0.44) 1.37  (0.88) 1.06  (0.25)
22.Secondary Outcome
Title Apparent Total Clearance (CL/F) of Esomeprazole After at Least 5 Days of Repeated Dose
Hide Description [Not Specified]
Time Frame 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:
D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
Overall Number of Participants Analyzed 7 9 10 9 10
Mean (Standard Deviation)
Unit of Measure: L/h
4.74  (1.92) 12.44  (8.90) 6.44  (3.37) 23.33  (24.93) 10.94  (3.64)
23.Secondary Outcome
Title Apparent Volume of Distribution (Vz/F) of Esomeprazole After at Least 5 Days of Repeated Dose
Hide Description [Not Specified]
Time Frame 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who had at least one plasma concentration data after administration of study drug without any protocol deviations that would have an impact on the PK.
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description:
D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
Overall Number of Participants Analyzed 7 9 10 9 10
Mean (Standard Deviation)
Unit of Measure: L
5.10  (1.24) 16.56  (16.21) 9.21  (4.00) 44.73  (72.03) 15.90  (4.42)
Time Frame Serious adverse events were collected from the date of signing of informed consent to 8 weeks or withdrawal. Other adverse events were collected from the start of investigational drug administration to 8 weeks or withdrawal.
Adverse Event Reporting Description During the administration period, the investigator/clinical research coordinator contacted the patient or patients’ guardian (e.g. by phone) at least once in every week to confirm patient’s health condition and compliance of study drug.
 
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Group 5
Hide Arm/Group Description D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
All-Cause Mortality
Group 1 Group 2 Group 3 Group 4 Group 5
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 Group 2 Group 3 Group 4 Group 5
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/10 (20.00%)      0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)      1/10 (10.00%)    
Gastrointestinal disorders           
Irritable bowel syndrome  1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Immune system disorders           
Anaphylactic reaction  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Asthma  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1 Group 2 Group 3 Group 4 Group 5
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/10 (80.00%)      8/10 (80.00%)      5/10 (50.00%)      5/10 (50.00%)      6/10 (60.00%)    
Blood and lymphatic system disorders           
Iron deficiency anaemia  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%) 
Eye disorders           
Hordeolum  1  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%) 
Gastrointestinal disorders           
Abdominal pain  1  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  1/10 (10.00%) 
Anal fissure  1  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Dental caries  1  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%) 
Diarrhoea  1  1/10 (10.00%)  0/10 (0.00%)  2/10 (20.00%)  0/10 (0.00%)  1/10 (10.00%) 
Gingival pain  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%) 
Haemorrhoidal haemorrhage  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%) 
Nausea  1  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  2/10 (20.00%) 
Stomatitis  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%) 
Vomiting  1  2/10 (20.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
General disorders           
Oedema peripheral  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%) 
Immune system disorders           
Seasonal allergy  1  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Infections and infestations           
Bronchitis  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Gastroenteritis  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%) 
Gastroenteritis viral  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%) 
Influenza  1  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Mumps  1  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Nasopharyngitis  1  1/10 (10.00%)  4/10 (40.00%)  2/10 (20.00%)  1/10 (10.00%)  3/10 (30.00%) 
Otitis media  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Paronychia  1  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Pharyngitis  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Pneumonia  1  2/10 (20.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Streptococcal infection  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Upper respiratory tract infection  1  1/10 (10.00%)  1/10 (10.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%) 
Varicella  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Vulvovaginal candidiasis  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Injury, poisoning and procedural complications           
Arthropod sting  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Nervous system disorders           
Headache  1  0/10 (0.00%)  2/10 (20.00%)  0/10 (0.00%)  0/10 (0.00%)  2/10 (20.00%) 
Respiratory, thoracic and mediastinal disorders           
Cough  1  1/10 (10.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%) 
Upper respiratory tract inflammation  1  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%)  1/10 (10.00%)  0/10 (0.00%) 
Skin and subcutaneous tissue disorders           
Photosensitivity reaction  1  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  0/10 (0.00%)  1/10 (10.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.0
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.
All PIs were prohibited to disclose all information related to this study without AstraZeneca approval before this study was completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Masahiro Nii
Organization: Biometrics Department, Science Affairs Division, R&D, AstraZeneca Japan
EMail: Masahiro.Nii@astrazeneca.com
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02153398     History of Changes
Other Study ID Numbers: D961TC00002
26-022 ( Other Identifier: PMDA )
First Submitted: May 30, 2014
First Posted: June 3, 2014
Results First Submitted: September 27, 2016
Results First Posted: January 19, 2017
Last Update Posted: January 19, 2017