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D961H sachet · 3 trials · 12 indications
The disappearance of heartburn was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of heartburn were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.
The disappearance of epigastric pain was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of epigastric pain were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.
The disappearance of upper abdominal discomfort was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of upper abdominal discomfort were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.
The disappearance of regurgitation was assessed by the intensity of the symptom at Week 8. Patients who recognized disappearance of regurgitation were defined as those who selected "Mild", "Moderate", or "Severe" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "None" at Week 8.
The aggravation of heartburn was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of heartburn were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.
The aggravation of epigastric pain was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of epigastric pain were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.
The aggravation of upper abdominal discomfort was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of upper abdominal discomfort were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.
The aggravation of regurgitation was assessed by the intensity of the symptom at Week 8. Patients who recognized aggravation of regurgitation were defined as those who selected "None" to the question about the intensity in the patient diary at pre-dose and had the maximum intensity of "Mild", "Moderate" or "Severe" at Week 8.
The investigators assessed the presence/absence and the intensity of heartburn at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized disappearance of heartburn were defined as those who had a heartburn at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.
The investigators assessed the presence/absence and the intensity of epigastric pain at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized disappearance of epigastric pain were defined as those who had an epigastric pain at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.
The investigators assessed the presence/absence and the intensity of upper abdominal discomfort at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized disappearance of upper abdominal discomfort were defined as those who had an upper abdominal discomfort at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.
The investigators assessed the presence/absence and the intensity of regurgitation at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized disappearance of regurgitation were defined as those who had a regurgitation at pre-dose and did not have the corresponding symptoms at Week 8 judged by investigators.
The investigators assessed the presence/absence and the intensity of heartburn at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized aggravation of heartburn were defined as those who had no heartburn at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.
The investigators assessed the presence/absence and the intensity of epigastric pain at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized aggravation of epigastric pain were defined as those who had no epigastric pain at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.
The investigators assessed the presence/absence and the intensity of upper abdominal discomfort at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized aggravation of upper abdominal discomfort were defined as those who had no upper abdominal discomfort at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.
The investigators assessed the presence/absence and the intensity of regurgitation at baseline and Week 8 based on questioning the patients or patients' guardians and the patient diary. Patients who recognized aggravation of regurgitation were defined as those who had no regurgitation at pre-dose and did have any of the corresponding symptoms at Week 8 judged by investigators.
To investigate whether a D961H sachet 20 mg is bioequivalent to a D961H HPMC capsule 20 mg after repeated oral doses by the assessment of percentage of time with intragastric pH\>4 during 24 hours after dose on Day 5.
* AUC(0-t)-Area under plasma concentration time curve from zero to time of the last measurable concentration * Cmax,ss - maximum concentration at steady state
| Arm | Type | Description |
|---|---|---|
| Group 1: D961H sachet 10 mg | EXPERIMENTAL | Age: ≥1 year Weight: \<20 kg |
| Group 2: D961H capsule 10mg | EXPERIMENTAL | Age: ≥1 year to 11years Weight: ≥20 kg |
| Group 3: D961H capsule 20 mg | EXPERIMENTAL | Age: ≥1 year to 11years Weight: ≥20 kg |
| Group 4: D961H capsule 10 mg | EXPERIMENTAL | Age: 12 to 14 years Weight: ≥20 kg |
| Group 5: D961H capsule 20 mg | EXPERIMENTAL | Age: 12 to 14 years Weight: ≥20 kg |
| D961H sachet 20 mg | EXPERIMENTAL | Pellets contains esomeprazole 20 mg (esomeprazole magnesium trihydrate 22.3 mg) and excipient granules filled into single-use aluminium sachets |
| D961H HPMC capsule 20 mg | OTHER | Pellets contains esomeprazole 20 mg (esomeprazole magnesium trihydrate 22.3 mg) in HPMC capsule |
| D961HHPMC Capsule 20 mg | EXPERIMENTAL | 2 way crossover |
| Name | Type | Description |
|---|---|---|
| D961H sachet 10 mg | DRUG | - |
| D961H capsule 10mg | DRUG | - |
| D961H capsule 20 mg | DRUG | - |
| D961H sachet 20 mg | DRUG | Each subject will be randomised evenly to one of "Treatment: A--\>B (Sequence 1)" or "Treatment: B--\>A (Sequence 2)". Treatment A: D961H sachet 20 mg Treatment B: D961H HPMC capsule 20 mg |
| D961H HPMC capsule 20 mg | DRUG | Each subject will be randomised evenly to one of "Treatment: A--\>B (Sequence 1)" or "Treatment: B--\>A (Sequence 2)". Treatment A: D961H sachet 20 mg Treatment B: D961H HPMC capsule 20 mg |
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 wei...
D961H Sachet is an investigational small molecule being studied for the treatment of gastric ulcer and other gastrointestinal acid-related diseases, including duodenal ulcer, anastomotic ulcer, reflux esophagitis, and Zollinger-Ellison syndrome. It is being developed by AstraZeneca PLC (AZN) and is currently in clinical development.
D961H Sachet is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The drug is an investigational small molecule intended for gastrointestinal acid-related conditions.
D961H Sachet is in Phase 1 clinical development. It has completed early-stage trials, including a Phase 1 bioequivalence study and a Phase 1 pharmacodynamics study. The drug is investigational and has not been approved for any use.
D961H Sachet has been studied in clinical trials registered under NCT01595425, NCT01964131, and NCT02153398. These trials evaluated the drug in Japanese healthy male subjects and pediatric patients with gastrointestinal acid-related diseases, including gastric ulcer and reflux esophagitis.
D961H Sachet and D961H Capsule are different formulations of the same drug. A completed bioequivalence study (NCT01595425) compared the sachet and capsule forms in Japanese healthy male subjects to assess whether the two formulations deliver the drug equivalently.