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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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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

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.

Condition or disease Intervention/treatment Phase
Gastric Ulcer (GU) Duodenal Ulcer (DU) Anastomotic Ulcer (AU) Non-erosive Reflux Esophagitis Disease (NERD) Reflux Esophagitis (RE) Zollinger-Ellison Syndrome Drug: D961H sachet 10 mg Drug: D961H capsule 10mg Drug: D961H capsule 20 mg Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Disappearance of Heartburn at Week 8 by Patient Diaries [ Time Frame: 8 weeks ]
    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.

  2. Disappearance of Epigastric Pain at Week 8 by Patient Diaries [ Time Frame: 8 weeks ]
    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.

  3. Disappearance of Upper Abdominal Discomfort at Week 8 by Patient Diaries [ Time Frame: 8 weeks ]
    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.

  4. Disappearance of Regurgitation at Week 8 by Patient Diaries [ Time Frame: 8 weeks ]
    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.

  5. Aggravation of Heartburn at Week 8 by Patient Diaries [ Time Frame: 8 weeks ]
    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.

  6. Aggravation of Epigastric Pain at Week 8 by Patient Diaries [ Time Frame: 8 weeks ]
    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.

  7. Aggravation of Upper Abdominal Discomfort at Week 8 by Patient Diaries [ Time Frame: 8 weeks ]
    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. Aggravation of Regurgitation at Week 8 by Patient Diaries [ Time Frame: 8 weeks ]
    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.

  9. Disappearance of Heartburn at Week 8 by Investigators [ Time Frame: 8 weeks ]
    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.

  10. Disappearance of Epigastric Pain at Week 8 by Investigators [ Time Frame: 8 weeks ]
    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.

  11. Disappearance of Upper Abdominal Discomfort at Week 8 by Investigators [ Time Frame: 8 weeks ]
    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.

  12. Disappearance of Regurgitation at Week 8 by Investigators [ Time Frame: 8 weeks ]
    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.

  13. Aggravation of Heartburn at Week 8 by Investigators [ Time Frame: 8 weeks ]
    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.

  14. Aggravation of Epigastric Pain at Week 8 by Investigators [ Time Frame: 8 weeks ]
    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.

  15. Aggravation of Upper Abdominal Discomfort at Week 8 by Investigators [ Time Frame: 8 weeks ]
    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.

  16. Aggravation of Regurgitation at Week 8 by Investigators [ Time Frame: 8 weeks ]
    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 :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153398


Locations
Japan
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
Sponsors and Collaborators
AstraZeneca

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02153398     History of Changes
Other Study ID Numbers: D961TC00002
26-022 ( Other Identifier: PMDA )
First Posted: June 3, 2014    Key Record Dates
Results First Posted: January 19, 2017
Last Update Posted: January 19, 2017
Last Verified: November 2016

Keywords provided by AstraZeneca:
Gastric ulcer (GU)
Duodenal ulcer (DU)
Anastomotic ulcer (AU)
Non-erosive reflux esophagitis disease (NERD)
Reflux esophagitis (RE)
Zollinger-Ellison syndrome

Additional relevant MeSH terms:
Ulcer
Gastroesophageal Reflux
Esophagitis
Stomach Ulcer
Duodenal Ulcer
Esophagitis, Peptic
Zollinger-Ellison Syndrome
Gastrinoma
Pathologic Processes
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Paraneoplastic Endocrine Syndromes
Paraneoplastic Syndromes
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Carcinoma, Islet Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pancreatic Neoplasms