phase I / III study to assess the safety, pharmacokinetics, pharmacodynamics and efficacy in Japanese paediatric patients
- Conditions
- Japanese paediatric patients 1 to 14 years old with gastrointestinal acid related diseasesTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2016-003775-22-Outside-EU/EEA
- Lead Sponsor
- AstraZeneca K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 50
·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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
·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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Safety and tolerability of repeated oncedaily oral administration of D961H 10 mg and D961H 20 mg;Secondary Objective: PK, PD, Efficacy;Primary end point(s): safety and tolerability by the assessment of adverse events, laboratory variables and vital signs;Timepoint(s) of evaluation of this end point: during the study period including run-in or washout periods
- Secondary Outcome Measures
Name Time Method