Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Esomeprazole (D961H) twice daily
Esomeprazole twice daily · 1 trial · 1 indication
Percentage of participants with healing of reflux esophagitis (RE) who were graded "O" (No RE) at Week 8 out of participants who were graded "A" (least severe) to "D" (most severe) at baseline according to Los Angeles classification
| Arm | Type | Description |
|---|---|---|
| D961H 20mg twice daily | EXPERIMENTAL | Double-blinded |
| D961H 20mg once daily | ACTIVE_COMPARATOR | Double-blinded |
| Name | Type | Description |
|---|---|---|
| Esomeprazole (D961H) twice daily | DRUG | One capsule of esomeprazole 20 mg (in the form of esomeprazole magnesium salt) will be administered in the morning and in the evening |
| Esomeprazole (D961H) once daily | DRUG | One capsule of esomeprazole 20 mg (in the form of esomeprazole magnesium salt) will be administered in the morning and one corresponding placebo capsule in the evening |
Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures. 2. Patients with RE classified into LA classification Grade A, B, C or D by Endoscopy despite of at least 8-week treatment using standard doses of PPIs. 3. Patients must fulfill at least one of the followin...
Esomeprazole twice daily is being studied for refractory reflux esophagitis, a form of inflammation of the lower esophagus that has not responded adequately to standard once-daily proton pump inhibitor therapy. It is an investigational twice-daily dosing regimen, not an approved treatment for this indication.
Esomeprazole twice daily targets ATP4A and ATP4B, the subunits of the gastric hydrogen-potassium ATPase, also known as the proton pump. It acts as an inhibitor of this enzyme, which is the final step in gastric acid secretion, thereby reducing acid production in the stomach.
Esomeprazole twice daily is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical program evaluating this dosing regimen in patients with refractory reflux esophagitis.
Esomeprazole twice daily is in Phase 3 clinical development. The program includes one completed Phase 3 trial, and no active trials are currently listed. It is an investigational regimen and has not been approved for the refractory reflux esophagitis indication.
Esomeprazole twice daily has been evaluated in the Phase 3 trial NCT01669811, titled "Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis." The trial was completed, enrolled 1,398 participants in Japan, and used a randomized, double-blind, active-controlled design.
Yes, esomeprazole twice daily is also known as esomeprazole (D961H) twice daily. D961H is the internal code used by AstraZeneca for esomeprazole in this clinical program. Both names refer to the same small-molecule proton pump inhibitor being studied in refractory reflux esophagitis.