Back to resultsA Phase I/III Study of D961H 10 mg and 20 mg in Japanese Paediatric Patients With Gastrointestinal Acid Related Diseases
Primary Purpose
Gastric Ulcer (GU), Duodenal Ulcer (DU), Anastomotic Ulcer (AU)
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
D961H sachet 10 mg
D961H capsule 10mg
D961H capsule 20 mg
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Ulcer (GU) focused on measuring Gastric ulcer (GU), Duodenal ulcer (DU), Anastomotic ulcer (AU), Non-erosive reflux esophagitis disease (NERD), Reflux esophagitis (RE), Zollinger-Ellison syndrome
Eligibility Criteria
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:
- 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
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
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- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Group 1: D961H sachet 10 mg
Group 2: D961H capsule 10mg
Group 3: D961H capsule 20 mg
Group 4: D961H capsule 10 mg
Group 5: D961H capsule 20 mg
Arm Description
Age: ≥1 year Weight: <20 kg
Age: ≥1 year to 11years Weight: ≥20 kg
Age: ≥1 year to 11years Weight: ≥20 kg
Age: 12 to 14 years Weight: ≥20 kg
Age: 12 to 14 years Weight: ≥20 kg
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Area Under the Plasma Concentration-time Curve During a Dosing Interval (AUCtau) of Esomeprazole After at Least 5 Days of Repeated Dose
AUC From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of Esomeprazole After at Least 5 Days of Repeated Dose
Maximum Plasma Concentration (Cmax) of Esomeprazole After at Least 5 Days of Repeated Dose
Time to Reach Maximum Plasma Concentration (Tmax) of Esomeprazole After at Least 5 Days of Repeated Dose
Elimination Half-life (t1/2) of Esomeprazole After at Least 5 Days of Repeated Dose
Apparent Total Clearance (CL/F) of Esomeprazole After at Least 5 Days of Repeated Dose
Apparent Volume of Distribution (Vz/F) of Esomeprazole After at Least 5 Days of Repeated Dose
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02153398
Brief Title
A Phase I/III Study of D961H 10 mg and 20 mg in Japanese Paediatric Patients With Gastrointestinal Acid Related Diseases
Official Title
An Open-label, Parallel-group, Multi-centre, Phase I/III Study 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 1 to 14 Years Old With Gastrointestinal Acid Related Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: D961H sachet 10 mg
Arm Type
Experimental
Arm Description
Age: ≥1 year Weight: <20 kg
Arm Title
Group 2: D961H capsule 10mg
Arm Type
Experimental
Arm Description
Age: ≥1 year to 11years Weight: ≥20 kg
Arm Title
Group 3: D961H capsule 20 mg
Arm Type
Experimental
Arm Description
Age: ≥1 year to 11years Weight: ≥20 kg
Arm Title
Group 4: D961H capsule 10 mg
Arm Type
Experimental
Arm Description
Age: 12 to 14 years Weight: ≥20 kg
Arm Title
Group 5: D961H capsule 20 mg
Arm Type
Experimental
Arm Description
Age: 12 to 14 years Weight: ≥20 kg
Intervention Type
Drug
Intervention Name(s)
D961H sachet 10 mg
Intervention Type
Drug
Intervention Name(s)
D961H capsule 10mg
Intervention Type
Drug
Intervention Name(s)
D961H capsule 20 mg
Primary Outcome Measure Information:
Title
Disappearance of Heartburn at Week 8 by Patient Diaries
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
Title
Disappearance of Epigastric Pain at Week 8 by Patient Diaries
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
Title
Disappearance of Upper Abdominal Discomfort at Week 8 by Patient Diaries
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
Title
Disappearance of Regurgitation at Week 8 by Patient Diaries
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
Title
Aggravation of Heartburn at Week 8 by Patient Diaries
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
Title
Aggravation of Epigastric Pain at Week 8 by Patient Diaries
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
Title
Aggravation of Upper Abdominal Discomfort at Week 8 by Patient Diaries
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
Title
Aggravation of Regurgitation at Week 8 by Patient Diaries
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
Title
Disappearance of Heartburn at Week 8 by Investigators
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
Title
Disappearance of Epigastric Pain at Week 8 by Investigators
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
Title
Disappearance of Upper Abdominal Discomfort at Week 8 by Investigators
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
Title
Disappearance of Regurgitation at Week 8 by Investigators
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
Title
Aggravation of Heartburn at Week 8 by Investigators
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
Title
Aggravation of Epigastric Pain at Week 8 by Investigators
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
Title
Aggravation of Upper Abdominal Discomfort at Week 8 by Investigators
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
Title
Aggravation of Regurgitation at Week 8 by Investigators
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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
Facility Information:
Facility Name
Research Site
City
Bunkyo-ku
Country
Japan
Facility Name
Research Site
City
Fukuoka-shi
Country
Japan
Facility Name
Research Site
City
Hiroshima-shi
Country
Japan
Facility Name
Research Site
City
Izumi-shi
Country
Japan
Facility Name
Research Site
City
Maebashi-shi
Country
Japan
Facility Name
Research Site
City
Matsumoto-shi
Country
Japan
Facility Name
Research Site
City
Osaka-shi
Country
Japan
Facility Name
Research Site
City
Saitama-shi
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
Country
Japan
Facility Name
Research Site
City
Setagaya-ku
Country
Japan
Facility Name
Research Site
City
Shimotsuke-shi
Country
Japan
Facility Name
Research Site
City
Shinjuku-ku
Country
Japan
Facility Name
Research Site
City
Suzaka-shi
Country
Japan
Facility Name
Research Site
City
Ureshino-shi
Country
Japan
Facility Name
Research Site
City
Yokohama-shi
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Phase I/III Study of D961H 10 mg and 20 mg in Japanese Paediatric Patients With Gastrointestinal Acid Related Diseases
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