NCT01093755

Brief Summary

The investigators hypothesize that intensive acid suppression with a long acting high potency proton pump inhibitor (PPI) drug dexlansoprazole will lead to a greater decrease in levels of inflammatory mediators (compared to conventional PPIs) in the esophagus, which could potentially lead to decreased recurrence of intestinal metaplasia following endoscopic ablation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

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

March 1, 2010

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2010

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

March 17, 2016

Completed
Last Updated

March 17, 2016

Status Verified

February 1, 2016

Enrollment Period

4.7 years

First QC Date

March 24, 2010

Results QC Date

February 19, 2016

Last Update Submit

February 19, 2016

Conditions

InflammationBarrett's Esophagus

Keywords

Barrett's EsophagusRadiofrequency ablationPatients post-radiofrequency ablation for Barrett's Esophagus.

Outcome Measures

Primary Outcomes (2)

  • Change in Inflammation Biomarker Tissue PGE2 Level

    Change from baseline in esophageal tissue biopsy prostaglandin E2 (PGE2) level, as determined by enzyme immunoassay

    3 months, 6 months

  • Change in Esophageal Inflammation Biomarker COX-2 Gene Expression

    Change from baseline in esophageal issue biopsy cyclooxygenase-2 (COX-2) gene expression, as determined by Western blot.

    3 months, 6 months

Study Arms (2)

dexlansoprazole

ACTIVE COMPARATOR

Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months

Drug: dexlansoprazole

omeprazole

ACTIVE COMPARATOR

Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.

Drug: Omeprazole

Interventions

dexlansoprazoleDRUG

Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months

Also known as: Dexilant
dexlansoprazole
OmeprazoleDRUG

Escalating doses of omeprazole (20-60 mg/day) for 6 months

Also known as: Prilosec
omeprazole

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Absence of intestinal metaplasia on endoscopy (under Narrow Band Imaging) and on histology (from biopsies taken from gastroesophageal junction and distal esophagus) on two successive surveillance endoscopies.
  • Able to consent to study
  • Males and females age 18-90
  • Life expectancy of 5 years or greater.

You may not qualify if:

  • Pregnancy
  • Inability to consent for the procedure
  • Anticoagulation therapy precluding performance of ambulatory pH monitoring and/or biopsies
  • Intolerance to proton pump inhibitors
  • Elevation in Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), (liver enzymes), bilirubin or alkaline phosphatase more than five times the upper limit of normal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

InflammationBarrett Esophagus

Interventions

DexlansoprazoleOmeprazole

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPrecancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Lansoprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Prasad Iyer, MD
Organization
Mayo Clinic
Iyer.Prasad@mayo.edu
507-284-0970

Study Officials

  • Prasad Iyer, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 24, 2010

First Posted

March 26, 2010

Study Start

March 1, 2010

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

March 17, 2016

Results First Posted

March 17, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)