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CompletedNCT02153398Updated Jan 19, 2017Results posted

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

A Phase 3 interventional study of D961H sachet 10 mg and D961H capsule 10mg in Gastric Ulcer (GU), Duodenal Ulcer (DU) and Anastomotic Ulcer (AU), sponsored by AstraZeneca. Completed at 15 sites in Japan. Open to participants aged 1 Year to 14 Years. Per ClinicalTrials.gov, last updated 2017-01-19.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
55
Allocation
Randomized
Ages
1 Year to 14 Years
Sex
All
01

Study summary

The objective of this study is to assess the safety, pharmacokinetics, pharmacodynamics and efficacy of repeated once daily oral administration of D961H 10 mg and D961H 20 mg in Japanese paediatric patients aged 1 to 14 years old who either have a diagnosis of or are suspected to have gastric ulcer (GU), duodenal ulcer (DU), anastomotic ulcer (AU), non-erosive reflux esophagitis disease (NERD), reflux esophagitis (RE) or Zollinger-Ellison syndrome.

02

Conditions studied

  • Gastric Ulcer (GU)
  • Duodenal Ulcer (DU)
  • Anastomotic Ulcer (AU)
  • Non-erosive Reflux Esophagitis Disease (NERD)
  • Reflux Esophagitis (RE)
  • Zollinger-Ellison Syndrome

Keywords

  • Gastric ulcer (GU)
  • Duodenal ulcer (DU)
  • Anastomotic ulcer (AU)
  • Non-erosive reflux esophagitis disease (NERD)
  • Reflux esophagitis (RE)
  • Zollinger-Ellison syndrome
03

In context

Gastrinoma

27 studies on the registry are indexed under Gastrinoma; none are open to participants now.

This study's enrollment of 55 is above the median of 27 across 19 interventional studies indexed under Gastrinoma.

Browse Gastrinoma studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Provision of signed written informed consent from the patient's guardian
  • Patients aged ≥ 1 year to 14 years old
  • Patients who have a diagnosis of or suspected to have GU, DU, AU, NERD, RE or Zollinger-Ellison syndrome.

Exclusion criteria

Exclusion Criteria:

  • Patients less than 10 kg in weight.
  • Use of any other investigational compounds or participations in another clinical trial within 4 weeks prior to the randomisation/registration.
  • Significant clinical illness within 4 weeks prior to the registration
  • Presence of hepatic diseases or other conditions that could interfere with evaluation of the study as judged by the investigators.
  • Positive for pregnancy test by urinary or lactation for post-menarchal females.
  • Previous total gastrectomy
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
55 participants (actual)

Study arms

  • Experimental
    Group 1: D961H sachet 10 mg

    Age: ≥1 year Weight: \<20 kg

    Drug: D961H sachet 10 mg

  • Experimental
    Group 2: D961H capsule 10mg

    Age: ≥1 year to 11years Weight: ≥20 kg

    Drug: D961H capsule 10mg

  • Experimental
    Group 3: D961H capsule 20 mg

    Age: ≥1 year to 11years Weight: ≥20 kg

    Drug: D961H capsule 20 mg

  • Experimental
    Group 4: D961H capsule 10 mg

    Age: 12 to 14 years Weight: ≥20 kg

    Drug: D961H capsule 10mg

  • Experimental
    Group 5: D961H capsule 20 mg

    Age: 12 to 14 years Weight: ≥20 kg

    Drug: D961H capsule 20 mg

Interventions

  • DrugD961H sachet 10 mg
  • DrugD961H capsule 10mg
  • DrugD961H capsule 20 mg
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8 weeks

  2. 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.

    Time frame: 8 weeks

  3. 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.

    Time frame: 8 weeks

  4. 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.

    Time frame: 8 weeks

  5. 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.

    Time frame: 8 weeks

  6. 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.

    Time frame: 8 weeks

  7. 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.

    Time frame: 8 weeks

  8. 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.

    Time frame: 8 weeks

  9. 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.

    Time frame: 8 weeks

  10. 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.

    Time frame: 8 weeks

  11. 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.

    Time frame: 8 weeks

  12. 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.

    Time frame: 8 weeks

  13. 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.

    Time frame: 8 weeks

  14. 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.

    Time frame: 8 weeks

  15. 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.

    Time frame: 8 weeks

  16. 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.

    Time frame: 8 weeks

Secondary outcomes

  1. Area Under the Plasma Concentration-time Curve During a Dosing Interval (AUCtau) of Esomeprazole After at Least 5 Days of Repeated Dose

    Time frame: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose

  2. AUC From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of Esomeprazole After at Least 5 Days of Repeated Dose

    Time frame: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose

  3. Maximum Plasma Concentration (Cmax) of Esomeprazole After at Least 5 Days of Repeated Dose

    Time frame: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose

  4. Time to Reach Maximum Plasma Concentration (Tmax) of Esomeprazole After at Least 5 Days of Repeated Dose

    Time frame: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose

  5. Elimination Half-life (t1/2) of Esomeprazole After at Least 5 Days of Repeated Dose

    Time frame: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose

  6. Apparent Total Clearance (CL/F) of Esomeprazole After at Least 5 Days of Repeated Dose

    Time frame: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose

  7. Apparent Volume of Distribution (Vz/F) of Esomeprazole After at Least 5 Days of Repeated Dose

    Time frame: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose

07

Results

Posted Jan 19, 2017

Participant flow

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.

Participant flow — Overall Study
MilestoneGroup 1Group 2Group 3Group 4Group 5
Started1010101010
Completed9109910
Not completed10110
Withdrew: Withdrawal by subject10000
Withdrew: Adverse event00110

Outcome measures

PrimaryDisappearance 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.

Time frame:
8 weeks
Reported as:
Number · Participants
Disappearance of Heartburn at Week 8 by Patient Diaries
ParticipantsGroup 1Group 2Group 3Group 4Group 5
Disappearance of Heartburn at Week 8 by Patient Diaries20013
PrimaryDisappearance 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.

Time frame:
8 weeks
Reported as:
Number · Participants
Disappearance of Epigastric Pain at Week 8 by Patient Diaries
ParticipantsGroup 1Group 2Group 3Group 4Group 5
Disappearance of Epigastric Pain at Week 8 by Patient Diaries23513
PrimaryDisappearance 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.

Time frame:
8 weeks
Reported as:
Number · Participants
Disappearance of Upper Abdominal Discomfort at Week 8 by Patient Diaries
ParticipantsGroup 1Group 2Group 3Group 4Group 5
Disappearance of Upper Abdominal Discomfort at Week 8 by Patient Diaries32422
PrimaryDisappearance 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.

Time frame:
8 weeks
Reported as:
Number · Participants
Disappearance of Regurgitation at Week 8 by Patient Diaries
ParticipantsGroup 1Group 2Group 3Group 4Group 5
Disappearance of Regurgitation at Week 8 by Patient Diaries32324
PrimaryAggravation 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.

Time frame:
8 weeks
Reported as:
Number · participants
Aggravation of Heartburn at Week 8 by Patient Diaries
participantsGroup 1Group 2Group 3Group 4Group 5
Aggravation of Heartburn at Week 8 by Patient Diaries00000
PrimaryAggravation 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.

Time frame:
8 weeks
Reported as:
Number · participants
Aggravation of Epigastric Pain at Week 8 by Patient Diaries
participantsGroup 1Group 2Group 3Group 4Group 5
Aggravation of Epigastric Pain at Week 8 by Patient Diaries00111
PrimaryAggravation 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.

Time frame:
8 weeks
Reported as:
Number · participants
Aggravation of Upper Abdominal Discomfort at Week 8 by Patient Diaries
participantsGroup 1Group 2Group 3Group 4Group 5
Aggravation of Upper Abdominal Discomfort at Week 8 by Patient Diaries00210
PrimaryAggravation 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.

Time frame:
8 weeks
Reported as:
Number · participants
Aggravation of Regurgitation at Week 8 by Patient Diaries
participantsGroup 1Group 2Group 3Group 4Group 5
Aggravation of Regurgitation at Week 8 by Patient Diaries20100
PrimaryDisappearance 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.

Time frame:
8 weeks
Reported as:
Number · Participants
Disappearance of Heartburn at Week 8 by Investigators
ParticipantsGroup 1Group 2Group 3Group 4Group 5
Disappearance of Heartburn at Week 8 by Investigators21—22
PrimaryDisappearance 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.

Time frame:
8 weeks
Reported as:
Number · Participants
Disappearance of Epigastric Pain at Week 8 by Investigators
ParticipantsGroup 1Group 2Group 3Group 4Group 5
Disappearance of Epigastric Pain at Week 8 by Investigators25426
PrimaryDisappearance 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.

Time frame:
8 weeks
Reported as:
Number · Participants
Disappearance of Upper Abdominal Discomfort at Week 8 by Investigators
ParticipantsGroup 1Group 2Group 3Group 4Group 5
Disappearance of Upper Abdominal Discomfort at Week 8 by Investigators35443
PrimaryDisappearance 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.

Time frame:
8 weeks
Reported as:
Number · Participants
Disappearance of Regurgitation at Week 8 by Investigators
ParticipantsGroup 1Group 2Group 3Group 4Group 5
Disappearance of Regurgitation at Week 8 by Investigators30313
PrimaryAggravation 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.

Time frame:
8 weeks
Reported as:
Number · Participants
Aggravation of Heartburn at Week 8 by Investigators
ParticipantsGroup 1Group 2Group 3Group 4Group 5
Aggravation of Heartburn at Week 8 by Investigators00010
PrimaryAggravation 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.

Time frame:
8 weeks
Reported as:
Number · Participants
Aggravation of Epigastric Pain at Week 8 by Investigators
ParticipantsGroup 1Group 2Group 3Group 4Group 5
Aggravation of Epigastric Pain at Week 8 by Investigators00000
PrimaryAggravation 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.

Time frame:
8 weeks
Reported as:
Number · Participants
Aggravation of Upper Abdominal Discomfort at Week 8 by Investigators
ParticipantsGroup 1Group 2Group 3Group 4Group 5
Aggravation of Upper Abdominal Discomfort at Week 8 by Investigators00010
PrimaryAggravation 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.

Time frame:
8 weeks
Reported as:
Number · Participants
Aggravation of Regurgitation at Week 8 by Investigators
ParticipantsGroup 1Group 2Group 3Group 4Group 5
Aggravation of Regurgitation at Week 8 by Investigators00101
SecondaryArea Under the Plasma Concentration-time Curve During a Dosing Interval (AUCtau) of Esomeprazole After at Least 5 Days of Repeated Dose
Time frame:
0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
Reported as:
Mean · μmol*h/L
Area Under the Plasma Concentration-time Curve During a Dosing Interval (AUCtau) of Esomeprazole After at Least 5 Days of Repeated Dose
μmol*h/LGroup 1Group 2Group 3Group 4Group 5
Area Under the Plasma Concentration-time Curve During a Dosing Interval (AUCtau) of Esomeprazole After at Least 5 Days of Repeated Dose7.04 ± 3.053.52 ± 2.3511.05 ± 5.112.38 ± 1.745.82 ± 1.85
SecondaryAUC From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of Esomeprazole After at Least 5 Days of Repeated Dose
Time frame:
0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
Reported as:
Mean · μmol*h/L
AUC From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of Esomeprazole After at Least 5 Days of Repeated Dose
μmol*h/LGroup 1Group 2Group 3Group 4Group 5
AUC From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of Esomeprazole After at Least 5 Days of Repeated Dose5.53 ± 3.693.09 ± 2.3410.41 ± 4.551.99 ± 1.305.45 ± 1.78
SecondaryMaximum Plasma Concentration (Cmax) of Esomeprazole After at Least 5 Days of Repeated Dose
Time frame:
0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
Reported as:
Mean · μmol/L
Maximum Plasma Concentration (Cmax) of Esomeprazole After at Least 5 Days of Repeated Dose
μmol/LGroup 1Group 2Group 3Group 4Group 5
Maximum Plasma Concentration (Cmax) of Esomeprazole After at Least 5 Days of Repeated Dose3.42 ± 2.092.09 ± 1.535.91 ± 2.191.09 ± 0.573.13 ± 1.36
SecondaryTime to Reach Maximum Plasma Concentration (Tmax) of Esomeprazole After at Least 5 Days of Repeated Dose
Time frame:
0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
Reported as:
Median · hour
Time to Reach Maximum Plasma Concentration (Tmax) of Esomeprazole After at Least 5 Days of Repeated Dose
hourGroup 1Group 2Group 3Group 4Group 5
Time to Reach Maximum Plasma Concentration (Tmax) of Esomeprazole After at Least 5 Days of Repeated Dose1.58 ± 2.091.52 ± 1.531.47 ± 2.191.57 ± 0.571.75 ± 1.36
SecondaryElimination Half-life (t1/2) of Esomeprazole After at Least 5 Days of Repeated Dose
Time frame:
0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
Reported as:
Mean · hour
Elimination Half-life (t1/2) of Esomeprazole After at Least 5 Days of Repeated Dose
hourGroup 1Group 2Group 3Group 4Group 5
Elimination Half-life (t1/2) of Esomeprazole After at Least 5 Days of Repeated Dose0.80 ± 0.180.97 ± 0.551.08 ± 0.441.37 ± 0.881.06 ± 0.25
SecondaryApparent Total Clearance (CL/F) of Esomeprazole After at Least 5 Days of Repeated Dose
Time frame:
0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
Reported as:
Mean · L/h
Apparent Total Clearance (CL/F) of Esomeprazole After at Least 5 Days of Repeated Dose
L/hGroup 1Group 2Group 3Group 4Group 5
Apparent Total Clearance (CL/F) of Esomeprazole After at Least 5 Days of Repeated Dose4.74 ± 1.9212.44 ± 8.906.44 ± 3.3723.33 ± 24.9310.94 ± 3.64
SecondaryApparent Volume of Distribution (Vz/F) of Esomeprazole After at Least 5 Days of Repeated Dose
Time frame:
0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
Reported as:
Mean · L
Apparent Volume of Distribution (Vz/F) of Esomeprazole After at Least 5 Days of Repeated Dose
LGroup 1Group 2Group 3Group 4Group 5
Apparent Volume of Distribution (Vz/F) of Esomeprazole After at Least 5 Days of Repeated Dose5.10 ± 1.2416.56 ± 16.219.21 ± 4.0044.73 ± 72.0315.90 ± 4.42

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group 1—2/10 (20%)8/10 (80%)
Group 2—0/10 (0%)8/10 (80%)
Group 3—0/10 (0%)5/10 (50%)
Group 4—0/10 (0%)5/10 (50%)
Group 5—1/10 (10%)6/10 (60%)
Most frequent serious events
Most frequent serious events
EventGroup 1Group 2Group 3Group 4Group 5
Anaphylactic reactionImmune system disorders1/100/100/100/100/10
AsthmaRespiratory, thoracic and mediastinal disorders1/100/100/100/100/10
Irritable bowel syndromeGastrointestinal disorders0/100/100/100/101/10
Most frequent other events
Showing 10 of 32
Most frequent other events
EventGroup 1Group 2Group 3Group 4Group 5
NasopharyngitisInfections and infestations1/104/102/101/103/10
PneumoniaInfections and infestations2/100/100/100/100/10
HeadacheNervous system disorders0/102/100/100/102/10
DiarrhoeaGastrointestinal disorders1/100/102/100/101/10
NauseaGastrointestinal disorders0/101/100/100/102/10
VomitingGastrointestinal disorders2/100/100/100/100/10
BronchitisInfections and infestations1/100/100/100/100/10
GastroenteritisInfections and infestations1/100/100/100/101/10
Gastroenteritis viralInfections and infestations0/100/100/101/100/10
InfluenzaInfections and infestations0/101/100/100/100/10

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Group 1Group 2Group 3Group 4Group 5Total
Mean3.6 ± 2.28.9 ± 0.78.4 ± 1.813.4 ± 0.713.1 ± 0.99.5 ± 3.9
Age, Customized
Age, Customized(Participants)Group 1Group 2Group 3Group 4Group 5Total
<= 3 years500005
4-5 years200002
6-7 years304007
8-9 years0830011
10-11 years023005
12-14 years000101020
Gender
Gender(Participants)Group 1Group 2Group 3Group 4Group 5Total
Female5627626
Male5483424
08

Study locations

15 sites
  • Research Site
    Bunkyo-ku, Japan
  • Research Site
    Fukuoka-shi, Japan
  • Research Site
    Hiroshima-shi, Japan
  • Research Site
    Izumi-shi, Japan
  • Research Site
    Maebashi-shi, Japan
  • Research Site
    Matsumoto-shi, Japan
  • Research Site
    Osaka-shi, Japan
  • Research Site
    Saitama-shi, Japan
  • Research Site
    Sapporo-shi, Japan
  • Research Site
    Setagaya-ku, Japan
  • Research Site
    Shimotsuke-shi, Japan
  • Research Site
    Shinjuku-ku, Japan
  • Research Site
    Suzaka-shi, Japan
  • Research Site
    Ureshino-shi, Japan
  • Research Site
    Yokohama-shi, Japan
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02153398
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Jun 3, 2014
Start date
Jun 2014
Primary completion
Apr 2016
Completion
Apr 2016
Results posted
Jan 19, 2017
Last update
Jan 19, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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