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Trial record 85 of 252 for:    ASPIRIN AND low-dose aspirin

A Study of Esomeplazole (D961H) in Japanese Paediatric Patients With Reflux Esophagitis, Gastric Ulcer or Duodenal Ulcer

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ClinicalTrials.gov Identifier: NCT03553563
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:

This is an open label, parallel group, multi-centre, phase III study to assess the safety and efficacy of D961H in maintenance therapy following initial healing therapy in Japanese paediatric patients with reflux esophagitis, and to assess the safety and efficacy of D961H in Japanese paediatric patients treated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy who have a documented medical history of gastric ulcer or duodenal ulcer diagnosis.

Doses of D961H in this study is set for the 2 groups (weight more than equal 10 kg to less than 20 kg and weight more than equal 20 kg) in the maintenance therapy for healed reflux esophagitis group and the prevention of gastric ulcer or duodenal ulcer recurrence by non-steroidal anti-inflammatory drugs or low-dose aspirin therapy group, Primary endpoints are evaluated at week 32. Further, this study is designed to evaluate the long term efficacy and safety of D961H for a maximum of 52 weeks, in consideration of the medical needs for long term proton pump inhibitor treatment. Patient can continue study treatment up to 52 weeks, if they want.


Condition or disease Intervention/treatment Phase
Reflux Esophagitis Gastric Ulcer Duodenal Ulcer Drug: D961H capsule 10mg Drug: D961H sachet 10mg Phase 3

Detailed Description:

Subjects are allocated to four groups based on their disease and weight.

Number of Subjects

Maintenance therapy for healed reflux esophagitis study part:

  • Group1:aged 1 to 14 years (weight more than equal 10 kg to less than 20 kg ), Maintenance phase, n=5 to 10
  • Group2:aged 1 to 14 years (weight more than equal 20 kg), Maintenance phase, n=10 to 20

Prevention of gastric ulcer or duodenal ulcer recurrence associated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy study part:

  • Group3:aged 1 to 14 years (weight more than equal 10 kg to less than 20 kg), n=5 to 10 at Week 0
  • Group4:aged 1 to 14 years (weight more than equal 20 kg), n=10 to 20 at Week 0

All subjects have a D961H administration for 32 or 52 weeks. all esophagogastroduodenoscopy findings are reviewed by central evaluation committee and study is conducted based on the judgement of central evaluation committee.

Data are entered in electric data capture system at study site by site staffs and all data are verified with source data by site monitors during the study.

Analyses will be performed by AstraZeneca or its representatives. A comprehensive statistical analysis plan will be developed and finalised before database lock and will describe the subject populations to be included in the analyses, and procedures for accounting for missing, unused, and spurious data. This section is a summary of the planned statistical analyses of the primary and secondary endpoints. Any deviations from this plan will be reported in the clinical study report.

Efficacy analyses are intended for Efficacy Analysis Set. ・Efficacy Analysis Set:All subjects who take at least 1 dose of the investigational product and have at least 1 efficacy datum assessment during the maintenance/prevention therapy period, and who have no important protocol deviation.

All safety analyses are performed on the Safety Analysis Set.

・Safety Analysis Set:All subjects who take at least 1 dose of the investigational product and have any post-treatment assessment.

Frequency and incidence rate of adverse events (AEs), serious adverse events (SAEs), discontinuation of investigational product due to adverse events (DAEs) and other significant adverse events (OAEs) will be presented by MedDRA System Organ Class (SOC) and Preferred Term (PT) for each group. In addition, summaries of AEs will be further broken down by maximum intensity and relationship to the investigational product as assigned by investigators.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: An open label, parallel four group, multi-centre, phase III study
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Open Label, Parallel Group, Multi-centre, Phase III Study to Assess the Efficacy and Safety of D961H for the Maintenance Therapy Following Initial Treatment in Japanese Paediatric Patients With Reflux Esophagitis and for the Prevention of Recurrence of Gastric Ulcer or Duodenal Ulcer in Japanese Paediatric Patients Treated With Non-steroidal Anti-inflammatory Drugs or Low-dose Aspirin
Actual Study Start Date : July 24, 2018
Estimated Primary Completion Date : January 4, 2023
Estimated Study Completion Date : January 4, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group1
Initial healing phase (8 weeks), D961H 10 mg once-daily; Maintenance phase (24 or 44 weeks), D961H 10 mg once-daily
Drug: D961H capsule 10mg
All Groups can select either capsule or sachet during the study.
Other Name: esomeprazole

Drug: D961H sachet 10mg
All Groups can select either capsule or sachet during the study.
Other Name: esomeprazole

Experimental: Group2
Initial healing phase (8 weeks), D961H 20 mg once-daily; Maintenance phase (24 or 44 weeks) starts with D961H 10 mg once-daily and may be increased to 20 mg once-daily based on investigator's discretion
Drug: D961H capsule 10mg
All Groups can select either capsule or sachet during the study.
Other Name: esomeprazole

Drug: D961H sachet 10mg
All Groups can select either capsule or sachet during the study.
Other Name: esomeprazole

Experimental: Group3
D961H 10 mg once-daily (32 or 52 weeks)
Drug: D961H capsule 10mg
All Groups can select either capsule or sachet during the study.
Other Name: esomeprazole

Drug: D961H sachet 10mg
All Groups can select either capsule or sachet during the study.
Other Name: esomeprazole

Experimental: Group4
D961H starts with 10 mg once-daily, and may be increased to 20 mg once-daily based on investigator's discretion (32 or 52 weeks)
Drug: D961H capsule 10mg
All Groups can select either capsule or sachet during the study.
Other Name: esomeprazole

Drug: D961H sachet 10mg
All Groups can select either capsule or sachet during the study.
Other Name: esomeprazole




Primary Outcome Measures :
  1. Presence/absence of reflux esophagitis relapse [ Time Frame: 8 to 32 weeks ]

    Maintenance therapy for healed reflux esophagitis study part:

    Presence/absence of reflux esophagitis relapse from 8 to 32 weeks for all subjects by assessment of the composite endpoint (reflux esophagitis -related symptoms or optional esophagogastroduodenoscopy findings) during the maintenance therapy.


  2. Adverse events during reflux esophagitis maintenance therapy [ Time Frame: 8 to 32 weeks ]

    Maintenance therapy for healed reflux esophagitis study part:

    Safety from 8 to 32 weeks for all subjects.


  3. Presence/absence of gastric ulcer or duodenal ulcer recurrence [ Time Frame: 0 to 32 weeks ]

    Prevention of gastric ulcer or duodenal ulcer recurrence associated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy study part:

    Presence/absence of gastric ulcer or duodenal ulcer recurrence from 0 to 32 weeks for all subjects by assessment of the composite endpoint (gastric ulcer or duodenal ulcer-related symptoms or optional esophagogastroduodenoscopy findings) during the prevention therapy.


  4. Adverse events during gastric ulcer or duodenal ulcer recurrence prevention therapy [ Time Frame: 0 to 32 weeks ]

    Prevention of gastric ulcer or duodenal ulcer recurrence associated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy study part:

    Safety from 0 to 32 weeks for all subjects.



Secondary Outcome Measures :
  1. Presence/absence of reflux esophagitis relapse [ Time Frame: 8 to 52 weeks ]
    Presence/absence of reflux esophagitis relapse from 8 to 52 weeks for subjects who continued the study treatment after Week 32 by assessment of the composite endpoint (reflux esophagitis-related symptoms or optional esophagogastroduodenoscopy findings) during the maintenance therapy.

  2. Adverse events during reflux esophagitis maintenance therapy [ Time Frame: 8 to 52 weeks ]

    Maintenance therapy for healed reflux esophagitis study part:

    Safety from 8 to 52 weeks for subjects who continued the study treatment after Week 32.


  3. Presence/absence of gastric ulcer or duodenal ulcer recurrence [ Time Frame: 0 to 52 weeks ]
    Presence/absence of gastric ulcer or duodenal ulcer recurrence from 0 to 52 weeks for subjects who continued the study treatment after Week 32 by assessment of the composite endpoint (gastric ulcer or duodenal ulcer-related symptoms or optional esophagogastroduodenoscopy findings) during the prevention therapy.

  4. Adverse events during gastric ulcer or duodenal ulcer recurrence prevention therapy [ Time Frame: 0 to 52 weeks ]

    Prevention of gastric ulcer or duodenal ulcer recurrence associated with long term non-steroidal anti-inflammatory drugs or low-dose aspirin therapy study part:

    Safety from 0 to 52 weeks for subjects who continued the study treatment after Week 32.




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:

For healed reflux esophagitis study

  • Endoscopically verified reflux esophagitis, Grade A or higher according to the Los Angels classification as judged by central evaluation committee.

For prevention of gastric ulcer or duodenal ulcer recurrence study

  • Patients with documented medical history of gastric ulser or duodenal ulser diagnosis based on upper gastrointestinal symptoms, fecal occult blood, esophagogastroduodenoscopy findings, etc.

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 enrolment.
  • Significant clinical illness within 4 weeks prior to the informed consent
  • Previous total gastrectomy.
  • Presence of hepatic diseases or other conditions that could interfere with evaluation of the study as judged by investigators. etc

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): NCT03553563


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Contact: Kazuhiko Motono, Phar.B. +81-80-4487-0284 Kazuhiko.Motono@astrazeneca.com

Locations
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Japan
Research Site Recruiting
Bunkyo-ku, Japan, 113-8431
Research Site Recruiting
Bunkyo-ku, Japan, 113-8519
Research Site Recruiting
Fuji-shi, Japan, 417-8567
Research Site Recruiting
Izumi-shi, Japan, 594-1101
Research Site Recruiting
Kagoshima-shi, Japan, 890-8520
Research Site Recruiting
Kanazawa-shi, Japan, 920-8641
Research Site Recruiting
Kyoto-shi, Japan, 602-8566
Research Site Recruiting
Maebashi-shi, Japan, 371-8511
Research Site Recruiting
Matsumoto-shi, Japan, 390-8621
Research Site Recruiting
Okayama-shi, Japan, 701-1192
Research Site Recruiting
Saitama-shi, Japan, 339-8551
Research Site Recruiting
Sakai-shi, Japan, 593-8304
Research Site Recruiting
Setagaya-ku, Japan, 157-8535
Research Site Recruiting
Shinjuku-ku, Japan, 160-0023
Research Site Recruiting
Takatsuki-shi, Japan, 569-8686
Research Site Recruiting
Yokohama-shi, Japan, 230-8765
Research Site Recruiting
Yokohama, Japan, 232 8555
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Chair: Toshiaki Shimizu, M.D., Ph.D. Juntendo University Graduate School of Medicine

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03553563     History of Changes
Other Study ID Numbers: D961WC00001
2018-000213-20 ( EudraCT Number )
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AstraZeneca:
D961H
paediatric
reflux esophagitis
gastric ulcer

Additional relevant MeSH terms:
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Ulcer
Gastroesophageal Reflux
Esophagitis
Stomach Ulcer
Duodenal Ulcer
Esophagitis, Peptic
Pathologic Processes
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Esomeprazole
Anti-Inflammatory Agents, Non-Steroidal
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents