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

Zollinger-Ellison Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02153398
• Other study ID #: D961TC00002
• Secondary ID: 26-022
• Status: Completed
• Phase: Phase 3
• First received: May 30, 2014
• Last updated: April 27, 2016
• Start date: June 2014
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 14 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anastomotic Ulcer (AU)
• Duodenal Ulcer
• Duodenal Ulcer (DU)
• Esophagitis
• Esophagitis, Peptic
• Gastric Ulcer (GU)
• Gastrinoma
• Gastroesophageal Reflux
• Non-erosive Reflux Esophagitis Disease (NERD)
• Reflux Esophagitis (RE)
• Stomach Ulcer
• Ulcer
• Zollinger-Ellison Syndrome

Intervention

Drug:
• D961H sachet 10 mg

• D961H capsule 10mg

• D961H capsule 20 mg

Locations

Country	Name	City	State
Japan	Research Site	Bunkyo-ku
Japan	Research Site	Fukuoka-shi
Japan	Research Site	Hiroshima-shi
Japan	Research Site	Izumi-shi
Japan	Research Site	Maebashi-shi
Japan	Research Site	Matsumoto-shi
Japan	Research Site	Osaka-shi
Japan	Research Site	Saitama-shi
Japan	Research Site	Sapporo-shi
Japan	Research Site	Setagaya-ku
Japan	Research Site	Shimotsuke-shi
Japan	Research Site	Shinjuku-ku
Japan	Research Site	Suzaka-shi
Japan	Research Site	Ureshino-shi
Japan	Research Site	Yokohama-shi

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Esophagogastroduodenoscopy(EGD) findings	Assessment of endoscopic presence/absence of GU, DU, AU or RE according to the EGD findings	Pre dose and after at least 5 days of repeated dose	No
Primary	Safety of D961H in terms of a panel of safety measures: adverse events, physical examination, vital signs and laboratory variables		From baseline to 8 weeks	Yes
Secondary	Pharmacodynamic variabilities by assessment of the percentages of time with intragastric pH >4 and pH>3 (percent of the time)		Pre dose (Week 0) and after at least 5 days of repeated dose (Week 1,4 or 8)	No
Secondary	Pharmacokinetics of esomeprazole and its metabolites by assessment of AUCtau, AUC0-t, Cmax, tmax, t½, CL/F and Vz/F	AUCtau, AUC0-t, Cmax, tmax, and t1/2 (For all) CL/F, Vz/F (For esomeprazole only) AUCtau:Area under the curve during a dosing interval, AUC0-t:AUC from time zero to time of last quantifiable concentration, Cmax:Maximum plasma concentration,tmax: Time to reach maximum plasma concentration, t½: Elimination half-life, CL/F: Apparent total clearance and Vz/F: Apparent volume of distribution during terminal phase	Pre dose (Week 0) and after at least 5 days of repeated dose (Week 1,4 or 8)	No
Secondary	The number of disappearance or aggravation of gastrointestinal symptom assessed by the investigators and the patient diaries		From baseline to 8 weeks	No
Secondary	Pharmacodynamic variabilities by assessment of median intragastric pH during 12 hours		Pre dose (Week 0) and after at least 5 days of repeated dose (Week 1,4 or 8)	No
Secondary	The percentage of disappearance or aggravation of gastrointestinal symptom assessed by the investigators and the patient diaries		From baseline to 8 weeks	No