| Primary | Disappearance of Heartburn at Week 8 by Patient Diaries | 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. | Participants who had heartburn at pre-dose in patient diary and obtained available diary data at Week 8. | Posted | | Number | | Participants | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group 1 | D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg | | OG001 | Group 2 | D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg | | OG002 | Group 3 | D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg | | OG003 | Group 4 | D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg | | OG004 | Group 5 | D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| Primary | Disappearance of Epigastric Pain at Week 8 by Patient Diaries | 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. | Participants who had epigastric pain at pre-dose in patient diary and obtained available diary data at Week 8. | Posted | | Number | | Participants | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group 1 | D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg | | OG001 | Group 2 | D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg | | OG002 | Group 3 | D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg | | OG003 | Group 4 | D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg | |
|
| Primary | Disappearance of Upper Abdominal Discomfort at Week 8 by Patient Diaries | 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. | Participants who had upper abdominal discomfort at pre-dose in patient diary and obtained available diary data at Week 8. | Posted | | Number | | Participants | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group 1 | D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg | | OG001 | Group 2 | D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg | | OG002 | Group 3 | D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg | | OG003 | Group 4 | D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg |
|
| Primary | Disappearance of Regurgitation at Week 8 by Patient Diaries | 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. | Participants who had regurgitation at pre-dose in patient diary and obtained available diary data at Week 8. | Posted | | Number | | Participants | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group 1 | D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg | | OG001 | Group 2 | D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg | | OG002 | Group 3 | D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg | | OG003 | Group 4 | D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg | |
|
| Primary | Aggravation of Heartburn at Week 8 by Patient Diaries | 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. | Participants who had no heartburn at pre-dose in patient diary and obtained available diary data at Week 8. | Posted | | Number | | participants | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group 1 | D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg | | OG001 | Group 2 | D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg | | OG002 | Group 3 | D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg | | OG003 | Group 4 | D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg | | OG004 |
|
| Primary | Aggravation of Epigastric Pain at Week 8 by Patient Diaries | 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. | Participants who had no epigastric pain at pre-dose in patient diary and obtained available diary data at Week 8. | Posted | | Number | | participants | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group 1 | D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg | | OG001 | Group 2 | D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg | | OG002 | Group 3 | D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg | | OG003 | Group 4 | D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg | |
|
| Primary | Aggravation of Upper Abdominal Discomfort at Week 8 by Patient Diaries | 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. | Participants who had no upper abdominal discomfort at pre-dose in patient diary and obtained available diary data at Week 8. | Posted | | Number | | participants | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group 1 | D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg | | OG001 | Group 2 | D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg | | OG002 | Group 3 | D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg | | OG003 | Group 4 | D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg |
|
| Primary | Aggravation of Regurgitation at Week 8 by Patient Diaries | 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. | Participants who had no regurgitation at pre-dose in patient diary and obtained available diary data at Week 8. | Posted | | Number | | participants | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group 1 | D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg | | OG001 | Group 2 | D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg | | OG002 | Group 3 | D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg | | OG003 | Group 4 | D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg | |
|
| Primary | Disappearance of Heartburn at Week 8 by Investigators | 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. | Participants who had a heartburn at pre-dose and were evaluated the symptom at Week 8 by investigators. | Posted | | Number | | Participants | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group 1 | D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg | | OG001 | Group 2 | D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg | | OG002 | Group 3 | D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg | | OG003 | Group 4 | D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg | |
|
| Primary | Disappearance of Epigastric Pain at Week 8 by Investigators | 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. | Participants who had an epigastric pain at pre-dose and were evaluated the symptom at Week 8 by investigators. | Posted | | Number | | Participants | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group 1 | D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg | | OG001 | Group 2 | D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg | | OG002 | Group 3 | D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg | | OG003 | Group 4 | D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg |
|
| Primary | Disappearance of Upper Abdominal Discomfort at Week 8 by Investigators | 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. | Participants who had an upper abdominal discomfort at pre-dose and were evaluated the symptom at Week 8 by investigators. | Posted | | Number | | Participants | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group 1 | D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg | | OG001 | Group 2 | D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg | | OG002 | Group 3 | D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg | | OG003 | Group 4 | D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg |
|
| Primary | Disappearance of Regurgitation at Week 8 by Investigators | 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. | Participants who had a regurgitation at pre-dose and were evaluated the symptom at Week 8 by investigators. | Posted | | Number | | Participants | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group 1 | D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg | | OG001 | Group 2 | D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg | | OG002 | Group 3 | D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg | | OG003 | Group 4 | D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg |
|
| Primary | Aggravation of Heartburn at Week 8 by Investigators | 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. | Participants who had no heartburn at pre-dose and were evaluated the symptom at Week 8 by investigators. | Posted | | Number | | Participants | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group 1 | D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg | | OG001 | Group 2 | D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg | | OG002 | Group 3 | D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg | | OG003 | Group 4 | D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg | |
|
| Primary | Aggravation of Epigastric Pain at Week 8 by Investigators | 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. | Participants who had no epigastric pain at pre-dose and were evaluated the symptom at Week 8 by investigators. | Posted | | Number | | Participants | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group 1 | D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg | | OG001 | Group 2 | D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg | | OG002 | Group 3 | D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg | | OG003 | Group 4 | D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg |
|
| Primary | Aggravation of Upper Abdominal Discomfort at Week 8 by Investigators | 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. | Participants who had no upper abdominal discomfort at pre-dose and were evaluated the symptom at Week 8 by investigators. | Posted | | Number | | Participants | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group 1 | D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg | | OG001 | Group 2 | D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg | | OG002 | Group 3 | D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg | | OG003 | Group 4 | D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg |
|
| Primary | Aggravation of Regurgitation at Week 8 by Investigators | 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. | Participants who had no regurgitation at pre-dose and were evaluated the symptom at Week 8 by investigators. | Posted | | Number | | Participants | | 8 weeks | | | | ID | Title | Description |
|---|
| OG000 | Group 1 | D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg | | OG001 | Group 2 | D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg | | OG002 | Group 3 | D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg | | OG003 | Group 4 | D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg |
|
| Secondary | Area Under the Plasma Concentration-time Curve During a Dosing Interval (AUCtau) of Esomeprazole After at Least 5 Days of Repeated Dose | | 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). | Posted | | Mean | Standard Deviation | μmol*h/L | | 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose | | | | ID | Title | Description |
|---|
| OG000 | Group 1 | D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg | | OG001 | Group 2 | D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg | | OG002 | Group 3 | D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg | | OG003 | Group 4 | D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg | | OG004 | Group 5 | |
|
| Secondary | AUC From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of Esomeprazole After at Least 5 Days of Repeated Dose | | 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. | Posted | | Mean | Standard Deviation | μmol*h/L | | 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose | | | | ID | Title | Description |
|---|
| OG000 | Group 1 | D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg | | OG001 | Group 2 | D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg | | OG002 | Group 3 | D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg | | OG003 | Group 4 | D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg | | OG004 | Group 5 | |
|
| Secondary | Maximum Plasma Concentration (Cmax) of Esomeprazole After at Least 5 Days of Repeated Dose | | 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. | Posted | | Mean | Standard Deviation | μmol/L | | 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose | | | | ID | Title | Description |
|---|
| OG000 | Group 1 | D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg | | OG001 | Group 2 | D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg | | OG002 | Group 3 | D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg | | OG003 | Group 4 | D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg | | OG004 | Group 5 | D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg |
|
| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) of Esomeprazole After at Least 5 Days of Repeated Dose | | 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. | Posted | | Median | Full Range | hour | | 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose | | | | ID | Title | Description |
|---|
| OG000 | Group 1 | D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg | | OG001 | Group 2 | D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg | | OG002 | Group 3 | D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg | | OG003 | Group 4 | D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg | | OG004 | Group 5 | D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg |
|
| Secondary | Elimination Half-life (t1/2) of Esomeprazole After at Least 5 Days of Repeated Dose | | 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. | Posted | | Mean | Standard Deviation | hour | | 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose | | | | ID | Title | Description |
|---|
| OG000 | Group 1 | D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg | | OG001 | Group 2 | D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg | | OG002 | Group 3 | D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg | | OG003 | Group 4 | D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg | | OG004 | Group 5 | D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg |
|
| Secondary | Apparent Total Clearance (CL/F) of Esomeprazole After at Least 5 Days of Repeated Dose | | 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. | Posted | | Mean | Standard Deviation | L/h | | 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose | | | | ID | Title | Description |
|---|
| OG000 | Group 1 | D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg | | OG001 | Group 2 | D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg | | OG002 | Group 3 | D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg | | OG003 | Group 4 | D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg | | OG004 | Group 5 | D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg |
|
| Secondary | Apparent Volume of Distribution (Vz/F) of Esomeprazole After at Least 5 Days of Repeated Dose | | 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. | Posted | | Mean | Standard Deviation | L | | 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose | | | | ID | Title | Description |
|---|
| OG000 | Group 1 | D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg | | OG001 | Group 2 | D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg | | OG002 | Group 3 | D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg | | OG003 | Group 4 | D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg | | OG004 | Group 5 | D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg |
|