Use Of Esomeprazole In Postoperative Bariatric Surgery Patients Users And Non-Users Of Nonsteroidal Anti-Inflammatory Drugs (NSAIDS)
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Bariatric Surgery
Intervention: Esomeprazole (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: AstraZeneca
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
Clinical Details
Official title: Use Of Esomeprazole In Postoperative Bariatric Surgery Patients Users And Non-Users Of Nonsteroidal Anti-Inflammatory Drugs (NSAIDS)
Study design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: To evaluate the efficacy of Esomeprazole in preventing anastomotic stomal ulcer after gastric bypass surgery for weight loss
Secondary outcome: To evaluate the efficacy of Esomeprazole in avoiding appearance of related peptic acid symptoms after gastric bypass surgery for weight loss.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: September 2005
Last updated: January 23, 2008
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