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

This study has been completed.

First Received on January 23, 2008. Last Updated on January 21, 2011 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00608712

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 IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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:

MedlinePlus related topics: Weight Control Weight Loss Surgery

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

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 [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the efficacy of Esomeprazole in avoiding appearance of related peptic acid symptoms after gastric bypass surgery for weight loss. [ Designated as safety issue: No ]

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:

Esomeprazole 20mg oral tablet

Other Name: Nexium

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

No publications provided

ClinicalTrials.gov Identifier:	NCT00608712 History of Changes
Other Study ID Numbers:	D9612L00097
Study First Received:	January 23, 2008
Last Updated:	January 21, 2011
Health Authority:	Brazil: Ministry of Health

Keywords provided by AstraZeneca:

bariatric surgery
ulcer prevention

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Omeprazole
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012