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OpenTrials
Completed

NCT Number: NCT00608712

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

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

Completed

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Key information

Conditions

Postoperative Bariatric Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Esomeprazole

Drug

Esomeprazole 20mg oral tablet

Other names: Nexium

Primary outcomes

  1. To evaluate the efficacy of Esomeprazole in preventing anastomotic stomal ulcer after gastric bypass surgery for weight loss

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Feb 6, 2008
Registry last updated
Jan 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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