NCT00608712

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2005

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 6, 2008

Completed
Last Updated

January 24, 2011

Status Verified

January 1, 2011

Enrollment Period

9 months

First QC Date

January 23, 2008

Last Update Submit

January 21, 2011

Conditions

Postoperative Bariatric Surgery

Keywords

bariatric surgeryulcer prevention

Outcome Measures

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.

Interventions

EsomeprazoleDRUG

Esomeprazole 20mg oral tablet

Also known as: Nexium

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Esomeprazole

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 23, 2008

First Posted

February 6, 2008

Study Start

November 1, 2005

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

January 24, 2011

Record last verified: 2011-01