Does Intensive Acid Suppression Reduce Esophageal Inflammation and Recurrent Barrett's Esophagus Following Ablation?

NCT ID: NCT01093755

Last Updated: 2016-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2014-11-30

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.

Detailed Description

Patients who achieve complete remission of intestinal metaplasia following ablation will be randomized (using concealed allocation, like the flip of a coin) to either intensive acid suppression with dexlansoprazole 60-90 mg/day or to symptom guided acid suppression with escalating doses of omeprazole (20-60 mg/day) for 6 months. Control of reflux will be assessed using 24 hour ambulatory pH monitoring. The need to escalate drug dosage at the 3 month visit will be determined by presence of excessive acid exposure on ambulatory pH monitoring. Biopsies of esophageal tissue will be obtained at baseline, then at 3 months and 6 months following randomization to measure changes in inflammatory biomarkers.

Conditions

Inflammation; Barrett's Esophagus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

dexlansoprazole

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

Group Type: ACTIVE_COMPARATOR

dexlansoprazole

Intervention Type: DRUG

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

omeprazole

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

Group Type: ACTIVE_COMPARATOR

Omeprazole

Intervention Type: DRUG

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

Interventions

dexlansoprazole

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

Intervention Type: DRUG

Omeprazole

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

Intervention Type: DRUG

Other Intervention Names

Dexilant; Prilosec

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Able to consent to study

3. Males and females age 18-90

4. Life expectancy of 5 years or greater.

Exclusion Criteria

1. Pregnancy

2. Inability to consent for the procedure

3. Anticoagulation therapy precluding performance of ambulatory pH monitoring and/or biopsies

4. Intolerance to proton pump inhibitors

5. Elevation in Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), (liver enzymes), bilirubin or alkaline phosphatase more than five times the upper limit of normal.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Prasad G. Iyer

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Prasad Iyer, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

09-007252

Identifier Type: -

Identifier Source: org_study_id