Phase 3 N=50 Randomized Treatment

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

Gastric Ulcer (GU) · Duodenal Ulcer (DU) · Anastomotic Ulcer (AU) · Non-erosive Reflux Esophagitis Disease (NERD) · Reflux Esophagitis (RE)

Bottom Line

View on ClinicalTrials.gov: NCT02153398 ↗

Enrolled (actual)

Serious AEs

6.0%

Results posted

Jan 2017

Primary outcome: Primary: Disappearance of Heartburn at Week 8 by Patient Diaries — 2; 0; 0; 1 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: D961H sachet 10 mg (Drug); D961H capsule 10mg (Drug); D961H capsule 20 mg (Drug)
Age: Pediatric · 1+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: Apr 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Disappearance of Heartburn at Week 8 by Patient Diaries	2; 0; 0; 1; 3	—
PRIMARY Disappearance of Epigastric Pain at Week 8 by Patient Diaries	2; 3; 5; 1; 3	—
PRIMARY Disappearance of Upper Abdominal Discomfort at Week 8 by Patient Diaries	3; 2; 4; 2; 2	—
PRIMARY Disappearance of Regurgitation at Week 8 by Patient Diaries	3; 2; 3; 2; 4	—
PRIMARY Aggravation of Heartburn at Week 8 by Patient Diaries	0; 0; 0; 0; 0	—
PRIMARY Aggravation of Epigastric Pain at Week 8 by Patient Diaries	0; 0; 1; 1; 1	—
PRIMARY Aggravation of Upper Abdominal Discomfort at Week 8 by Patient Diaries	0; 0; 2; 1; 0	—
PRIMARY Aggravation of Regurgitation at Week 8 by Patient Diaries	2; 0; 1; 0; 0	—
PRIMARY Disappearance of Heartburn at Week 8 by Investigators	2; 1; 2; 2	—
PRIMARY Disappearance of Epigastric Pain at Week 8 by Investigators	2; 5; 4; 2; 6	—
PRIMARY Disappearance of Upper Abdominal Discomfort at Week 8 by Investigators	3; 5; 4; 4; 3	—
PRIMARY Disappearance of Regurgitation at Week 8 by Investigators	3; 0; 3; 1; 3	—
PRIMARY Aggravation of Heartburn at Week 8 by Investigators	0; 0; 0; 1; 0	—
PRIMARY Aggravation of Epigastric Pain at Week 8 by Investigators	0; 0; 0; 0; 0	—
PRIMARY Aggravation of Upper Abdominal Discomfort at Week 8 by Investigators	0; 0; 0; 1; 0	—
PRIMARY Aggravation of Regurgitation at Week 8 by Investigators	0; 0; 1; 0; 1	—
SECONDARY Area Under the Plasma Concentration-time Curve During a Dosing Interval (AUCtau) of Esomeprazole After at Least 5 Days of Repeated Dose	7.04; 3.52; 11.05; 2.38; 5.82	—
SECONDARY AUC From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of Esomeprazole After at Least 5 Days of Repeated Dose	5.53; 3.09; 10.41; 1.99; 5.45	—
SECONDARY Maximum Plasma Concentration (Cmax) of Esomeprazole After at Least 5 Days of Repeated Dose	3.42; 2.09; 5.91; 1.09; 3.13	—
SECONDARY Time to Reach Maximum Plasma Concentration (Tmax) of Esomeprazole After at Least 5 Days of Repeated Dose	1.58; 1.52; 1.47; 1.57; 1.75	—
SECONDARY Elimination Half-life (t1/2) of Esomeprazole After at Least 5 Days of Repeated Dose	0.80; 0.97; 1.08; 1.37; 1.06	—
SECONDARY Apparent Total Clearance (CL/F) of Esomeprazole After at Least 5 Days of Repeated Dose	4.74; 12.44; 6.44; 23.33; 10.94	—
SECONDARY Apparent Volume of Distribution (Vz/F) of Esomeprazole After at Least 5 Days of Repeated Dose	5.10; 16.56; 9.21; 44.73; 15.90	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02153398). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.