CompletedPhase 3

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

Japan55 participantsStarted 2014-06

Plain-language 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.

Who can participate

Age range

1 Year – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Disappearance of Heartburn at Week 8 by Patient Diaries

Timeframe: 8 weeks

Disappearance of Epigastric Pain at Week 8 by Patient Diaries

Timeframe: 8 weeks

Disappearance of Upper Abdominal Discomfort at Week 8 by Patient Diaries

Timeframe: 8 weeks

Disappearance of Regurgitation at Week 8 by Patient Diaries

Timeframe: 8 weeks

Aggravation of Heartburn at Week 8 by Patient Diaries

Timeframe: 8 weeks

Aggravation of Epigastric Pain at Week 8 by Patient Diaries

Timeframe: 8 weeks

Aggravation of Upper Abdominal Discomfort at Week 8 by Patient Diaries

Timeframe: 8 weeks

Trial details

NCT IDNCT02153398

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-04

Results submitted2016-09-27

View on ClinicalTrials.gov More Gastric Ulcer (GU) trials

Plain-language summary

Who can participate

Age range

1 Year – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Disappearance of Heartburn at Week 8 by Patient Diaries

Timeframe: 8 weeks

Disappearance of Epigastric Pain at Week 8 by Patient Diaries

Timeframe: 8 weeks

Disappearance of Upper Abdominal Discomfort at Week 8 by Patient Diaries

Timeframe: 8 weeks

Disappearance of Regurgitation at Week 8 by Patient Diaries

Timeframe: 8 weeks

Aggravation of Heartburn at Week 8 by Patient Diaries

Timeframe: 8 weeks

Aggravation of Epigastric Pain at Week 8 by Patient Diaries

Timeframe: 8 weeks

Aggravation of Upper Abdominal Discomfort at Week 8 by Patient Diaries

Timeframe: 8 weeks