Status:
COMPLETED
Use Of Esomeprazole In Postoperative Bariatric Surgery Patients Users And Non-Users Of Nonsteroidal Anti-Inflammatory Drugs (NSAIDS)
Lead Sponsor:
AstraZeneca
Conditions:
Postoperative Bariatric Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 re...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00608712
Start Date
November 1 2005
End Date
August 1 2006
Last Update
January 24 2011
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