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

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ClinicalTrials.gov Identifier: NCT00608712
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : January 24, 2011
Sponsor:
Information provided by:
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

Condition or disease Intervention/treatment Phase
Postoperative Bariatric Surgery Drug: Esomeprazole Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Use Of Esomeprazole In Postoperative Bariatric Surgery Patients Users And Non-Users Of Nonsteroidal Anti-Inflammatory Drugs (NSAIDS)
Study Start Date : November 2005
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Esomeprazole
    Esomeprazole 20mg oral tablet
    Other Name: Nexium


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

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

ClinicalTrials.gov Identifier: NCT00608712     History of Changes
Other Study ID Numbers: D9612L00097
First Posted: February 6, 2008    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
bariatric surgery
ulcer prevention

Additional relevant MeSH terms:
Esomeprazole
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents