E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Japanese paediatric patients 1 to 14 years old with gastrointestinal acid related diseases |
|
E.1.1.1 | Medical condition in easily understood language |
gastrointestinal acid related diseases |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Safety and tolerability of repeated oncedaily oral administration of D961H 10 mg and D961H 20 mg |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
・Provision of signed written informed consent from the patient’s guardian (including informed consent to a genetic test) prior to conducting of any study-related procedure and assent from the patient if possible.
・Patients aged ≥ 1 year to 14 years old inclusive at the time of informed consent.
・Patients who have a diagnosis of or suspected to have GU, DU, AU, NERD, RE or Zollinger-Ellison syndrome.
・Patient’s BMI must be between the 10th and 90th percentile for his/her age. |
|
E.4 | Principal 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 randomisation/registration, e.g., unintentional weight loss, gastrointestinal bleeding requiring abstinence from food, jaundice, or any other signs indicating serious or malignant diseases.
・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
・Need for H. pylori eradication therapy during the study period.
・Use of any PPIs within 14 days prior to the randomisation/registration. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
safety and tolerability by the assessment of adverse events, laboratory variables and vital signs |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
during the study period including run-in or washout periods |
|
E.5.2 | Secondary end point(s) |
・PK
− To assess the pharmacokinetics with the PK parameters [AUCtau (AUC during a dosing interval), AUC 0-t, Cmax, tmax, t1/2, apparent total clearance (CL/F) and apparent volume of distributionduring terminal phase (Vz/F)] of esomeprazole
− To assess the pharmacokinetics with the PK parameters (AUCtau, AUC0-t, Cmax, tmax, and t1/2) of the 5-hydroxy and sulphone metabolites of esomeprazole
・PD
− To assess percentages of time with intragastric pH > 4 and pH > 3, and median intragastric pH during 12-hours by intragastric pH monitoring
• Efficacy
− To assess the clinical outcome by the assessment of presence /absence and severity of upper gastrointestinal symptoms (heartburn, epigastric pain, upper abdominal discomfort and regurgitation). |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
PK
after at least 5 days of repeated oral administration of D961H 10 mg and D961H 20 mg.
・PD
at pre-dose and after at least 5 days of repeated oral administration of D961H 10 mg and D961H 20 mg in a subset of subjects.
• Efficacy
compared to baseline after 1, 4 and 8 weeks administration of D961H 10 mg and D961H 20 mg. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
|
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 5 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |