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

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca

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