Does Intensive Acid Suppression Reduce Esophageal Inflammation and Recurrent Barrett's Esophagus Following Ablation?
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|ClinicalTrials.gov Identifier: NCT01093755|
Recruitment Status : Completed
First Posted : March 26, 2010
Results First Posted : March 17, 2016
Last Update Posted : March 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Inflammation Barrett's Esophagus||Drug: dexlansoprazole Drug: Omeprazole||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Does Intensive Acid Suppression Reduce Esophageal Inflammation and Recurrent Barrett's Esophagus Following Ablation?: A Randomized Controlled Trial|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
Active Comparator: dexlansoprazole
Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months
Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months
Other Name: Dexilant
Active Comparator: omeprazole
Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.
Escalating doses of omeprazole (20-60 mg/day) for 6 months
Other Name: Prilosec
- Change in Inflammation Biomarker Tissue PGE2 Level [ Time Frame: 3 months, 6 months ]Change from baseline in esophageal tissue biopsy prostaglandin E2 (PGE2) level, as determined by enzyme immunoassay
- Change in Esophageal Inflammation Biomarker COX-2 Gene Expression [ Time Frame: 3 months, 6 months ]Change from baseline in esophageal issue biopsy cyclooxygenase-2 (COX-2) gene expression, as determined by Western blot.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01093755
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Prasad Iyer, MD||Mayo Clinic|