Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Esomeprazole, Esomeprazole (D961H), Esomeprazole (Nexium), Esomeprazole IV, Double Blind Esomeprazole
Esomeprazole/ASA · 36 trials · 27 indications
Criteria for a clinically significant upper GI bleeding as: 1. Bright red blood per NG or OG tube that did not clear after NG or OG tube adjustment and 5 to 10 minutes of at least 100 ml lavage with room temperature normal saline-or, 2. Persistent gastroccult- positive coffee ground material During IMP treatment Day 1-2: Persistent gastroccult- positive coffee ground material for at least eight consecutive hours that did not clear with at least 100 ml of lavage with room temperature normal saline. During IMP treatment Day 3-14: Persistent gastroccult- positive coffee ground material in at least three consecutive gastric aspirates within 2 to 4 hours (at least 60 ±20 minutes apart), that did not clear with at least 100 ml of lavage with room temperature normal saline.
Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D throughout the treatment period was evaluated.
Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C, Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break \< 5 mm in length), Grade B (Mucosal break \> 5mm), Grade C (Mucosal break continuous between \> 2 mucosal folds) and Grade D (Mucosal break \>75% of esophageal circumference).
The absence of gastric and/or duodenal ulcer throughout the treatment period
The occurrence of ulcer (mucosal break measuring \>= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.
The number of events are normalized prior to summary to correspond to a complete 8-hour monitoring period. Only patients with data at both baseline and final assessment are included.
Healed was defined as the absence of gastric ulcers. It was calculated as the proportion of subjects whose gastric ulcer(s) healed after 4 weeks treatment. (Ulcers were on S stage, stage 1 = Nonblanchable erythema of intact skin, stage 2 = Partial thickness skin loss involving epidermis, dermis, or both, stage 3 = Full thickness skin loss involving damage to or necrosis of subcutaneous tissue, stage 4 = Full thickness skin loss with extensive destruction, tissue necrosis, or damage to muscle, bone, or supporting structures or absent).
Death is recorded on a continuous basis through reporting from trial sites. Oesophageal adenocarcinoma is recorded through endoscopies taken every two years or ad-hoc at clinician decision High Grade Dysplasia is recorded through endoscopies taken every two years or ad-hoc at clinician decision
Treatment failure in the surgical arm defined when need for medical treatment for control of symptoms from reflux disease. Treatment failure in the medical arm defined when need for treatment other than esomeprazole for control of symptoms of reflux disease.
Compare on demand (taken as needed by the patient to adequately control their reflux disease) with continuous treatment of endoscopy negative subjects with gastroesophageal reflux disease (GERD), with esomeprazole 20-mg once daily, with regards to willingness to continue in the study as a result of satisfactory treatment over a six-month long term management period, after initial symptom relief
Peak expiratory flow is defined as the maximum speed of expiration as measured with the Mini-Wright® PEF Meter. Participants must have both baseline and follow up measure to be included in analysis. Results presented as a mean of all available data during the treatment period.
Dyspeptic symptoms severity will be assessed with validated 7-graded diary cards. The diary cards asked "Please state for each day if you have experienced pain or discomfort in the stomach." Measure taken over 7 consecutive days of a 2 week run in and at the end of each therapeutic period.
| Arm | Type | Description |
|---|---|---|
| Esomeprazole active treatment | EXPERIMENTAL | iv esomeprazole 30 min intermittent infusions given for maximum 14 days |
| Cimetidine active treatment | ACTIVE_COMPARATOR | iv cimetidine 30 min bolus infusion followed by iv cimetidine continuous infusion given for maximum 14 days |
| Esomeprazole 20 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| 1 | EXPERIMENTAL | Esomeprazole and Omeprazole |
| 2 | EXPERIMENTAL | Esomeprazole |
| 3 | ACTIVE_COMPARATOR | Omeprazole 20mg |
| Esomeprazole 40 mg | EXPERIMENTAL | Esomeprazole 40 mg |
| Arm A | EXPERIMENTAL | 20mg Esomeprazole |
| Arm B | EXPERIMENTAL | 80mg Esomeprazole |
| Arm C | EXPERIMENTAL | 20mg Esomeprazole + 300mg Aspirin |
| Arm D | EXPERIMENTAL | 80mg Esomeprazole + 300mg Aspirin |
| On demand 20 mg esomeprazole | EXPERIMENTAL | On demand treatment with 20-mg esomeprazole once daily when needed |
| Continuous 20 mg esomeprazole | ACTIVE_COMPARATOR | Continuous treatment with 20 mg esomeprazole once daily |
| Esomeprazole 40 mg twice daily | EXPERIMENTAL | - |
| Esomeprazole 40 mg once daily | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Esomeprazole | DRUG | iv esomeprazole 30 min intermittent infusions given for maximum 14 days |
| Cimetidine | DRUG | iv cimetidine 30 min bolus infusion followed by iv cimetidine continuous infusion given for maximum 14 days |
| Omeprazole | DRUG | 10mg once daily oral administration |
| Esomeprazole 20 mg | DRUG | Esomeprazole 20 mg once daily |
| Placebo | DRUG | once daily oral |
| Esomeprazole 40 mg | DRUG | Esomeprazole 40 mg once daily |
| Esomeprazole IV | DRUG | - |
| Omeprazole IV | DRUG | - |
| Ranitidine | DRUG | - |
| Aspirin | DRUG | 300mg per day |
| Esomeprazole (Nexium) | DRUG | - |
| Matching placebo | DRUG | Oral Once Daily |
| Laparoscopic fundoplication (surgery) | PROCEDURE | Surgery |
| naproxen | DRUG | 250mg, oral dose |
| Esomeprazole/ASA Fixed Combination | DRUG | Capsule, oral, single dose |
| Esomeprazole - Nexium | DRUG | Clinical Trial Capsule or MUPS Tablet, oral, single dose |
| ASA | DRUG | Tablet, oral, single dose |
| Esomeprazole 40mg/ASA 325mg | DRUG | combination capsule, administered as a single oral dose |
Inclusion Criteria: 1. Critically ill patients 2. Requirement for mechanical ventilation 3. At least one major risk factor for stress ulcer related bleeding Exclusion Criteria: 1. History of gastric or oesophageal surgery 2. Evidence of active GI bleeding 3. Advanced renal disease 4. Treatment wi...
Esomeprazole/ASA is a fixed-dose combination under study for gastroesophageal reflux and related upper gastrointestinal conditions, with research also exploring asthma, chest pain, esophageal cancer, gastric ulcer, and GERD. It pairs esomeprazole, a proton pump inhibitor, with acetylsalicylic acid. The combination is being developed by AstraZeneca PLC.
Esomeprazole/ASA targets ATP4A and ATP4B, the subunits of the gastric proton pump. Esomeprazole acts as an inhibitor of this pump, reducing gastric acid secretion. The acetylsalicylic acid component is an antiplatelet and analgesic agent. This dual mechanism underlies its investigation across reflux, ulcer, and related gastrointestinal indications.
Esomeprazole/ASA is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor behind the clinical program evaluating this fixed-dose combination across gastrointestinal and respiratory indications.
Esomeprazole/ASA is in Phase 2 development. It is investigational and has not been approved for the indications under study. The program includes four completed clinical trials with a total enrollment of 3,561 participants, all randomized, double-blind, and placebo-controlled.
Four completed trials have evaluated esomeprazole/ASA. NCT02670642 studied on-demand versus continuous esomeprazole in GERD across Europe and South Africa. NCT02157376 examined intravenous esomeprazole for stress ulcer prophylaxis in Chinese patients. NCT01370538 and NCT01370525 tested esomeprazole in frequent heartburn in the United States.
Esomeprazole/ASA is a fixed-dose combination containing esomeprazole, also known as Nexium, together with acetylsalicylic acid. Esomeprazole alone is the proton pump inhibitor component. The combination is also referred to as esomeprazole 40mg/ASA 325mg or the esomeprazole/ASA fixed dose combination.