Clinical trial NCT02153398: A Phase I/III Study of D961H 10 mg and 20 mg in Japanese Paediatric Patients With Gastrointestinal Acid Related Diseases
Official title: An Open-label, Parallel-group, Multi-centre, Phase I/III Study 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 1 to 14 Years Old With Gastrointestinal Acid Related Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Ulcer (GU)
Duodenal Ulcer (DU)
Anastomotic Ulcer (AU)
Non-erosive Reflux Esophagitis Disease (NERD)
Reflux Esophagitis (RE)
Zollinger-Ellison Syndrome
Keywords: Gastric ulcer (GU)
Duodenal ulcer (DU)
Anastomotic ulcer (AU)
Non-erosive reflux esophagitis disease (NERD)
Reflux esophagitis (RE)
Zollinger-Ellison syndrome
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-06-03
Enrollment: 55
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Disappearance of Heartburn at Week 8 by Patient Diaries
timeFrame: 8 weeks
measure: Disappearance of Epigastric Pain at Week 8 by Patient Diaries
timeFrame: 8 weeks
measure: Disappearance of Upper Abdominal Discomfort at Week 8 by Patient Diaries
timeFrame: 8 weeks
measure: Disappearance of Regurgitation at Week 8 by Patient Diaries
timeFrame: 8 weeks
measure: Aggravation of Heartburn at Week 8 by Patient Diaries
timeFrame: 8 weeks
measure: Aggravation of Epigastric Pain at Week 8 by Patient Diaries
timeFrame: 8 weeks
measure: Aggravation of Upper Abdominal Discomfort at Week 8 by Patient Diaries
timeFrame: 8 weeks
measure: Aggravation of Regurgitation at Week 8 by Patient Diaries
timeFrame: 8 weeks
measure: Disappearance of Heartburn at Week 8 by Investigators
timeFrame: 8 weeks
measure: Disappearance of Epigastric Pain at Week 8 by Investigators
timeFrame: 8 weeks
measure: Disappearance of Upper Abdominal Discomfort at Week 8 by Investigators
timeFrame: 8 weeks
measure: Disappearance of Regurgitation at Week 8 by Investigators
timeFrame: 8 weeks
measure: Aggravation of Heartburn at Week 8 by Investigators
timeFrame: 8 weeks
measure: Aggravation of Epigastric Pain at Week 8 by Investigators
timeFrame: 8 weeks
measure: Aggravation of Upper Abdominal Discomfort at Week 8 by Investigators
timeFrame: 8 weeks
measure: Aggravation of Regurgitation at Week 8 by Investigators
timeFrame: 8 weeks
Secondary outcomes:
measure: Area Under the Plasma Concentration-time Curve During a Dosing Interval (AUCtau) of Esomeprazole After at Least 5 Days of Repeated Dose
timeFrame: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
measure: AUC From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of Esomeprazole After at Least 5 Days of Repeated Dose
timeFrame: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
measure: Maximum Plasma Concentration (Cmax) of Esomeprazole After at Least 5 Days of Repeated Dose
timeFrame: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
measure: Time to Reach Maximum Plasma Concentration (Tmax) of Esomeprazole After at Least 5 Days of Repeated Dose
timeFrame: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
measure: Elimination Half-life (t1/2) of Esomeprazole After at Least 5 Days of Repeated Dose
timeFrame: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
measure: Apparent Total Clearance (CL/F) of Esomeprazole After at Least 5 Days of Repeated Dose
timeFrame: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
measure: Apparent Volume of Distribution (Vz/F) of Esomeprazole After at Least 5 Days of Repeated Dose
timeFrame: 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
Other outcomes:
Locations:
city: Bunkyo-ku
country: Japan
facility: Research Site
city: Fukuoka-shi
country: Japan
facility: Research Site
city: Hiroshima-shi
country: Japan
facility: Research Site
city: Izumi-shi
country: Japan
facility: Research Site
city: Maebashi-shi
country: Japan
facility: Research Site
city: Matsumoto-shi
country: Japan
facility: Research Site
city: Osaka-shi
country: Japan
facility: Research Site
city: Saitama-shi
country: Japan
facility: Research Site
city: Sapporo-shi
country: Japan
facility: Research Site
city: Setagaya-ku
country: Japan
facility: Research Site
city: Shimotsuke-shi
country: Japan
facility: Research Site
city: Shinjuku-ku
country: Japan
facility: Research Site
city: Suzaka-shi
country: Japan
facility: Research Site
city: Ureshino-shi
country: Japan
facility: Research Site
city: Yokohama-shi
country: Japan
facility: Research Site
Study officials:
References: