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

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

Sponsors

Lead Sponsor: AstraZeneca

Source AstraZeneca
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.

Overall Status Completed
Start Date 2014-06-01
Completion Date 2016-04-01
Primary Completion Date 2016-04-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Disappearance of Heartburn at Week 8 by Patient Diaries 8 weeks
Disappearance of Epigastric Pain at Week 8 by Patient Diaries 8 weeks
Disappearance of Upper Abdominal Discomfort at Week 8 by Patient Diaries 8 weeks
Disappearance of Regurgitation at Week 8 by Patient Diaries 8 weeks
Aggravation of Heartburn at Week 8 by Patient Diaries 8 weeks
Aggravation of Epigastric Pain at Week 8 by Patient Diaries 8 weeks
Aggravation of Upper Abdominal Discomfort at Week 8 by Patient Diaries 8 weeks
Aggravation of Regurgitation at Week 8 by Patient Diaries 8 weeks
Disappearance of Heartburn at Week 8 by Investigators 8 weeks
Disappearance of Epigastric Pain at Week 8 by Investigators 8 weeks
Disappearance of Upper Abdominal Discomfort at Week 8 by Investigators 8 weeks
Disappearance of Regurgitation at Week 8 by Investigators 8 weeks
Aggravation of Heartburn at Week 8 by Investigators 8 weeks
Aggravation of Epigastric Pain at Week 8 by Investigators 8 weeks
Aggravation of Upper Abdominal Discomfort at Week 8 by Investigators 8 weeks
Aggravation of Regurgitation at Week 8 by Investigators 8 weeks
Secondary Outcome
Measure Time Frame
Area Under the Plasma Concentration-time Curve During a Dosing Interval (AUCtau) of Esomeprazole After at Least 5 Days of Repeated Dose 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
AUC From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of Esomeprazole After at Least 5 Days of Repeated Dose 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
Maximum Plasma Concentration (Cmax) of Esomeprazole After at Least 5 Days of Repeated Dose 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
Time to Reach Maximum Plasma Concentration (Tmax) of Esomeprazole After at Least 5 Days of Repeated Dose 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
Elimination Half-life (t1/2) of Esomeprazole After at Least 5 Days of Repeated Dose 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
Apparent Total Clearance (CL/F) of Esomeprazole After at Least 5 Days of Repeated Dose 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
Apparent Volume of Distribution (Vz/F) of Esomeprazole After at Least 5 Days of Repeated Dose 0, 0.5, 1, 1.5, 2, 3, 4 and 6 hours post-dose after at least 5 days of repeated dose
Enrollment 55
Condition
Intervention

Intervention Type: Drug

Intervention Name: D961H sachet 10 mg

Arm Group Label: Group 1: D961H sachet 10 mg

Intervention Type: Drug

Intervention Name: D961H capsule 10mg

Intervention Type: Drug

Intervention Name: D961H capsule 20 mg

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

Gender:

All

Minimum Age:

1 Year

Maximum Age:

14 Years

Healthy Volunteers:

No

Location
Facility:
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, Japan
Location Countries

Japan

Verification Date

2016-11-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 5
Arm Group

Label: Group 1: D961H sachet 10 mg

Type: Experimental

Description: Age: ≥1 year Weight: <20 kg

Label: Group 2: D961H capsule 10mg

Type: Experimental

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

Label: Group 3: D961H capsule 20 mg

Type: Experimental

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

Label: Group 4: D961H capsule 10 mg

Type: Experimental

Description: Age: 12 to 14 years Weight: ≥20 kg

Label: Group 5: D961H capsule 20 mg

Type: Experimental

Description: Age: 12 to 14 years Weight: ≥20 kg

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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