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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00608712
First Posted: February 6, 2008
Last Update Posted: January 24, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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 Intervention Phase
Postoperative Bariatric Surgery Drug: Esomeprazole Phase 4

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

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

Enrollment: 140
Study Start Date: November 2005
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Esomeprazole
    Esomeprazole 20mg oral tablet
    Other Name: Nexium
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

ClinicalTrials.gov Identifier: NCT00608712     History of Changes
Other Study ID Numbers: D9612L00097
First Submitted: January 23, 2008
First Posted: February 6, 2008
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