NCT02153398

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
10 months until next milestone

Results Posted

Study results publicly available

January 19, 2017

Completed
Last Updated

January 19, 2017

Status Verified

November 1, 2016

Enrollment Period

1.8 years

First QC Date

May 30, 2014

Results QC Date

September 27, 2016

Last Update Submit

November 28, 2016

Conditions

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

Outcome Measures

Primary Outcomes (16)

  • 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.

    8 weeks

  • 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.

    8 weeks

  • 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.

    8 weeks

  • 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.

    8 weeks

  • 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.

    8 weeks

  • 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.

    8 weeks

  • 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.

    8 weeks

  • 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.

    8 weeks

  • 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.

    8 weeks

  • 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.

    8 weeks

  • 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.

    8 weeks

  • 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.

    8 weeks

  • 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.

    8 weeks

  • 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.

    8 weeks

  • 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.

    8 weeks

  • 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.

    8 weeks

Secondary Outcomes (7)

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

    0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose 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

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

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

    0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose 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

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

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

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

  • +2 more secondary outcomes

Study Arms (5)

Group 1: D961H sachet 10 mg

EXPERIMENTAL

Age: ≥1 year Weight: \<20 kg

Drug: D961H sachet 10 mg

Group 2: D961H capsule 10mg

EXPERIMENTAL

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

Drug: D961H capsule 10mg

Group 3: D961H capsule 20 mg

EXPERIMENTAL

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

Drug: D961H capsule 20 mg

Group 4: D961H capsule 10 mg

EXPERIMENTAL

Age: 12 to 14 years Weight: ≥20 kg

Drug: D961H capsule 10mg

Group 5: D961H capsule 20 mg

EXPERIMENTAL

Age: 12 to 14 years Weight: ≥20 kg

Drug: D961H capsule 20 mg

Interventions

D961H sachet 10 mgDRUG
Group 1: D961H sachet 10 mg
D961H capsule 10mgDRUG
Group 2: D961H capsule 10mgGroup 4: D961H capsule 10 mg
D961H capsule 20 mgDRUG
Group 3: D961H capsule 20 mgGroup 5: D961H capsule 20 mg

Eligibility Criteria

Age1 Year - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Research Site

Bunkyō City, Japan

Location

Research Site

Fukuoka, Japan

Location

Research Site

Hiroshima, Japan

Location

Research Site

Izumi-shi, Japan

Location

Research Site

Maebashi, Japan

Location

Research Site

Matsumoto-shi, Japan

Location

Research Site

Osaka, Japan

Location

Research Site

Saitama-shi, Japan

Location

Research Site

Sapporo, Japan

Location

Research Site

Setagaya-ku, Japan

Location

Research Site

Shimotsuke-shi, Japan

Location

Research Site

Shinjuku-ku, Japan

Location

Research Site

Suzaka-shi, Japan

Location

Research Site

Ureshino-shi, Japan

Location

Research Site

Yokohama, Japan

Location

MeSH Terms

Conditions

Stomach UlcerDuodenal UlcerEsophagitis, PepticZollinger-Ellison Syndrome

Condition Hierarchy (Ancestors)

Peptic UlcerDuodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach DiseasesEsophagitisEsophageal DiseasesGastroenteritisParaneoplastic Endocrine SyndromesParaneoplastic SyndromesNeoplasmsGastrointestinal NeoplasmsDigestive System Neoplasms

Results Point of Contact

Title
Masahiro Nii
Organization
Biometrics Department, Science Affairs Division, R&D, AstraZeneca Japan
Masahiro.Nii@astrazeneca.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2014

First Posted

June 3, 2014

Study Start

June 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

January 19, 2017

Results First Posted

January 19, 2017

Record last verified: 2016-11

Locations

JP(15)