Use Of Esomeprazole In Postoperative Bariatric Surgery Patients Users And Non-Users Of Nonsteroidal Anti-Inflammatory Drugs (NSAIDS)
Phase 4
Completed
- Conditions
- Postoperative Bariatric Surgery
- Registration Number
- NCT00608712
- Lead Sponsor
- AstraZeneca
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of Esomeprazole in preventing anastomotic stomal ulcer after gastric bypass surgery for weight loss
- Secondary Outcome Measures
Name Time Method To evaluate the efficacy of Esomeprazole in avoiding appearance of related peptic acid symptoms after gastric bypass surgery for weight loss.