Stress Ulcer Prophylaxis of Intravenous Esomeprazole in Chinese Seriously Ill Patients (SUP)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Stress Ulcer Prophylaxis

Treatments: Drug: Cimetidine; Drug: Esomeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT02157376

D961OC00002

Details and patient eligibility

About

The efficacy of esomeprazole will be compared versus cimetidine (a drug that previously demonstrated prevention of bleeding events) during treatment period in proportion of patients for the prevention of upper GI bleeding.

Full description

Stress related upper Gastrointestinal (GI) bleedings are important events associated with morbidity and mortality among seriously ill patients. Data from the literature suggest that stress ulcer prevention with effective acid suppressive treatment can reduce bleeding events and is thus an important therapy in high-risk patients. Esomeprazole has the potential to reduce gastric acidity for prolonged periods of time adequate for both preventing mucosal damage and facilitating coagulation. This study is to reveal whether intravenous (iv) esomeprazole is effective in preventing upper gastrointestinal bleeding and if it is tolerated by Chinese seriously ill patients.

Enrollment: 343 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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 with any Proton Pump Inhibitors

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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343 participants in 2 patient groups

Esomeprazole active treatment

Experimental group

Description:

iv esomeprazole 30 min intermittent infusions given for maximum 14 days

Treatment:

Drug: Esomeprazole

Cimetidine active treatment

Active Comparator group

Description:

iv cimetidine 30 min bolus infusion followed by iv cimetidine continuous infusion given for maximum 14 days

Treatment:

Drug: Cimetidine