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Label indication NEXIUM is a proton pump inhibitor (PPI). NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for the: • Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. ( 1.1 ) • Maintenance of healing of EE in adults. FDA label
Also known as Nexium
Esomeprazole Na · 2 trials · 2 indications
Presence/absence of Erosive Esophagitis for all patients by assessment of Esophagogastroduodenoscopy at the end of the 16-week maintenance phase
Diagnostic criteria for clinically significant rebleeding based on either A, B or C: A) Endoscopy - initiated by clinical signs of bleeding defined as one of B1 or B2 or B3 and endoscopic verification, ie one of A1 or A2. A1: Blood in stomach (this criteria cannot be used during the first 6 hours after primary endoscopic haemostasis). A2: A verified active bleeding from a peptic ulcer (Forrest Ia, Ib). B) A true clinically based definition, at least two of B1 and/or B2 and/or B3. B1: Vomiting of fresh blood or fresh blood in a gastric tube or haematochezia or melaena after a normal stool. B2: Decrease in Hb \>20g/L (or Hct \>6%) during 24 hours or an increase in Hb \<10g/L (or Hct \<3%) despite ≥2 units of blood has been transfused during 24hours. B3: Unstable circulation systolic blood pressure ≤ 90 mmHg or pulse ≥110/min (after have had a stable circulation). C) Haematemesis. Vomiting significant amounts (\>200 ml) of fresh blood as estimated by the investigator.
| Arm | Type | Description |
|---|---|---|
| Nexium - high dose | ACTIVE_COMPARATOR | Arm 1 (High dose = Healing dose) |
| Nexium - Low dose | ACTIVE_COMPARATOR | Arm 2 (Low dose = ½ healing dose) |
| Esomeprazole | EXPERIMENTAL | - |
| Cimetidine | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Nexium 20mg | DRUG | Nexium® (Esomeprazole) gastro-resistant granules for oral suspension 10 or 20 mg taken once daily for 8 weeks, and then 10 or 5 mg taken once daily for 16 weeks. |
| Nexium 10mg | DRUG | Nexium® (Esomeprazole) gastro-resistant granules for oral suspension 10 or 20 mg taken once daily for 8 weeks, and then 10 or 5 mg taken once daily for 16 weeks. |
| Esomeprazole Na | DRUG | Given as 80mg bolus infusion during 30 min and then 8mg/h constant infusion during 71.5 hous |
| Cimetidine | DRUG | Given as 200mg bolus infusion during 30 min and then 60mg/h constant infusion during 71.5 hours |
| Esomeprazole Mg | DRUG | 40 mg tablet once daily for 27 days |
Inclusion Criteria: 1. Patient must be 1 to 11 years of age 2. Patients must have a clinical history of GERD for at least 3 months before the start of study 3. For the healing phase: Patients must have confirmed presence of EE at endoscopy performed within one week of the start of the healing phase...
Esomeprazole Na is being studied for the prevention of rebleeding after successful endoscopic therapy of a bleeding peptic ulcer. The Phase 3 trial enrolled 239 adults in China. It is an investigational use of the drug in this setting, and the trial has been completed.
Esomeprazole Na targets ATP4A and ATP4B, subunits of the gastric proton pump. It acts as an inhibitor of this pump, which is the mechanism behind its suppression of gastric acid secretion. This target class is relevant to its evaluation in bleeding peptic ulcer.
Esomeprazole Na is developed by AstraZeneca PLC, which trades under the ticker AZN. The company is the sponsor behind the clinical program evaluating the drug in bleeding peptic ulcer.
Esomeprazole Na is in Phase 3 development for bleeding peptic ulcer. The program includes one completed Phase 3 trial, and no trials are currently active. It remains an investigational use in this indication rather than an approved one.
Esomeprazole Na has been evaluated in the Phase 3 trial NCT01757275, titled High Dose Esomeprazole Na for Prevention of Rebleeding After Successful Endoscopic Therapy of a Bleeding Peptic Ulcer. The trial was completed, enrolled 239 participants, and was randomized, double blind, and active controlled.