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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Duodenal Ulcer (DU); Zollinger-Ellison Syndrome; Gastric Ulcer (GU); Non-erosive Reflux Esophagitis Disease (NERD); Reflux Esophagitis (RE); Anastomotic Ulcer (AU)

Treatments: Drug: D961H sachet 10 mg; Drug: D961H capsule 10mg; Drug: D961H capsule 20 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02153398

26-022 (Other Identifier)

D961TC00002

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 1 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 5 patient groups

Group 1: D961H sachet 10 mg

Experimental group

Description:

Age: ≥1 year Weight: \<20 kg

Treatment:

Drug: D961H sachet 10 mg

Group 2: D961H capsule 10mg

Experimental group

Description:

Age: ≥1 year to 11years Weight: ≥20 kg

Treatment:

Drug: D961H capsule 10mg

Group 3: D961H capsule 20 mg

Experimental group

Description:

Age: ≥1 year to 11years Weight: ≥20 kg

Treatment:

Drug: D961H capsule 20 mg

Group 4: D961H capsule 10 mg

Experimental group

Description:

Age: 12 to 14 years Weight: ≥20 kg

Treatment:

Drug: D961H capsule 10mg

Group 5: D961H capsule 20 mg

Experimental group

Description:

Age: 12 to 14 years Weight: ≥20 kg

Treatment:

Drug: D961H capsule 20 mg