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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Prasad G. Iyer, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01093755
First received: March 24, 2010
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

The investigators hypothesize that intensive acid suppression with a long acting high potency proton pump inhibitor (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.


Condition Intervention Phase
Inflammation
Barrett's Esophagus
Drug: dexlansoprazole
Drug: Omeprazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Does Intensive Acid Suppression Reduce Esophageal Inflammation and Recurrent Barrett's Esophagus Following Ablation?: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Inflammation reduction [ Time Frame: 6-24 months ] [ Designated as safety issue: No ]
    We hypothesize that intensive acid suppression will reduce inflammation associated markers in the esophagus with a potential reduction in the rate of recurrent BE following ablation.


Estimated Enrollment: 60
Study Start Date: March 2010
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: dexlansoprazole
patients will be treated with dexlansoprazole 60 mg/day for 6 months
Drug: dexlansoprazole
Other Name: Dexilant
Active Comparator: omeprazole
patients will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.
Drug: Omeprazole
Other Name: Prilosec

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Patients who have undergone ablation for BE and HGD or LGD with PDT/Radiofrequency ablation and endoscopic mucosal resection who have no endoscopic and histologic evidence of specialized intestinal metaplasia on biopsies from the esophagus on two successive endoscopies post ablation will be offered enrollment in the study.

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 AST, ALT, Bilirubin or alkaline phosphatase more than five times the upper limit of normal.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01093755

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Ganapathy Prasad, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Prasad G. Iyer, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01093755     History of Changes
Other Study ID Numbers: 09-007252
Study First Received: March 24, 2010
Last Updated: July 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Barrett's esophagus
Radiofrequency ablation
Patients post-radiofrequency ablation for barrett's esophagus.

Additional relevant MeSH terms:
Barrett Esophagus
Inflammation
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Pathologic Processes
Omeprazole
Dexlansoprazole
Lansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014