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: January 23, 2008 Last Updated: March 10, 2009 History of Changes

Sponsored by:	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

MedlinePlus related topics: Surgery Weight Control Weight Loss Surgery

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Use Of Esomeprazole In Postoperative Bariatric Surgery Patients Users And Non-Users Of Nonsteroidal Anti-Inflammatory Drugs (NSAIDS)

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:	September 2005
Study Completion Date:	August 2006

Intervention Details:

Esomeprazole 20mg oral tablet

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

Study ID Numbers:	D9612L00097
Study First Received:	January 23, 2008
Last Updated:	March 10, 2009
ClinicalTrials.gov Identifier:	NCT00608712 History of Changes
Health Authority:	Brazil: Ministry of Health

Keywords provided by AstraZeneca:

bariatric surgery
ulcer prevention

Study placed in the following topic categories:

Anti-Inflammatory Agents
Analgesics, Non-Narcotic
Ulcer
Omeprazole

Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Omeprazole
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Ulcer Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 07, 2009