Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
D961H Sachet · 2 trials · 11 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.
| 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 |
| 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 developed by AstraZeneca PLC for gastrointestinal acid related diseases, including gastric ulcer. It is a sachet formulation studied in Japanese patients and healthy volunteers. The program has completed two clinical trials, and the drug remains in clinical development rather than being an approved product.
D961H Sachet is being studied for gastric ulcer and other gastrointestinal acid related diseases. Trial NCT02153398 enrolled Japanese pediatric patients with gastric ulcer, duodenal ulcer, anastomotic ulcer, non-erosive reflux esophagitis disease, reflux esophagitis, and Zollinger-Ellison syndrome. The sachet formulation is also being evaluated for use in these acid related conditions.
AstraZeneca PLC develops D961H Sachet. The company trades under the ticker AZN. Both completed trials of the sachet formulation were conducted in Japan, one in pediatric patients with gastrointestinal acid related diseases and one in healthy adult male subjects.
D961H Sachet is in Phase 3 development. The Phase I/III study NCT02153398 in Japanese pediatric patients with gastrointestinal acid related diseases reached Phase 3 and is completed. The drug is investigational and has not been approved for marketing based on the available development information.
Two completed trials have studied D961H Sachet. NCT02153398 was a Phase I/III study of the 10 mg and 20 mg sachet in Japanese pediatric patients with gastrointestinal acid related diseases, enrolling 55 participants. NCT01964131 was a Phase 1 bioavailability study comparing a capsule and a sachet formulation in 34 healthy Japanese male subjects.