Use Of Esomeprazole In Postoperative Bariatric Surgery Patients Users And Non-Users Of Nonsteroidal Anti-Inflammatory Drugs (NSAIDS)

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Postoperative Bariatric Surgery

Treatments: Drug: Esomeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00608712

D9612L00097

Details and patient eligibility

About

Phase IV, open-label, multicenter, non-randomized, with 2 non-comparative investigational arms study, carried out in morbid obesity patients who had undergone gastric bypass surgery for body weight reduction

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent signed and dated
• BMI ≥40 kg/m2 or BMI between 35 and 40 kg/m2, but with a severe disease together with obesity
• Indication for gastric bypass surgery
• Upper digestive endoscopy prior to surgery not showing esophagitis, erosions, ulcers or neoplasia, examination performed up to 30 days before surgery being considered valid
• Helicobacter pylori non-infected patients, diagnosed by tests carried out up to 30 days before surgery

Exclusion criteria

• Contraindication for gastric bypass surgery
• Contraindication to use Omeprazole and derivatives
• Patients carriers of gastrinoma or having hypergastrinemia
• Patients contraindicated to perform UDE
• Patients with previous esophagogastroduodenal surgery

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)