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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00608712

Enrollment

140

Registered

2008-02-06

Start date

2005-11-30

Completion date

2006-08-31

Last updated

2011-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Bariatric Surgery

Keywords

bariatric surgery, ulcer prevention

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

Interventions

DRUGEsomeprazole

Esomeprazole 20mg oral tablet

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of Esomeprazole in preventing anastomotic stomal ulcer after gastric bypass surgery for weight loss	—

Secondary

Measure	Time frame
To evaluate the efficacy of Esomeprazole in avoiding appearance of related peptic acid symptoms after gastric bypass surgery for weight loss.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026