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Completed

NCT Number: NCT02153398

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

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.

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Key information

Conditions

Gastric Ulcer (GU) Anastomotic Ulcer (AU) Digestive System Diseases Digestive System Neoplasms Duodenal Diseases Duodenal Ulcer Duodenal Ulcer (DU) Esophageal Diseases Esophagitis Esophagitis, Peptic Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Neoplasms Non-erosive Reflux Esophagitis Disease (NERD) Paraneoplastic Endocrine Syndromes Paraneoplastic Syndromes Peptic Ulcer Reflux Esophagitis (RE) Stomach Diseases Stomach Ulcer Zollinger-Ellison Syndrome

Age range

1 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Bunkyō City, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

D961H sachet 10 mg

Drug

D961H capsule 10mg

Drug

D961H capsule 20 mg

Drug

Primary outcomes

  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 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 3, 2014
Registry last updated
Jan 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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