Ignite Creation Date:
2024-05-05 @ 10:23 PM
Last Modification Date:
2024-10-26 @ 10:17 AM
Study NCT ID:
NCT01093755
Status:
COMPLETED
Last Update Posted:
2016-03-17
First Post:
2010-03-24
Brief Title:
Does Intensive Acid Suppression Reduce Esophageal Inflammation and Recurrent Barretts Esophagus Following Ablation
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Does Intensive Acid Suppression Reduce Esophageal Inflammation and Recurrent Barretts Esophagus Following Ablation A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgday or to symptom guided acid suppression with escalating doses of omeprazole 20-60 mgday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None