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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dexlansoprazole | Active Comparator | Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexlansoprazole | Drug | Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Patients who have undergone ablation for Barrett's Esophagus (BE) and High Grade Dysplasia (HGD) or Low Grade Dysplasia (LGD) with Photodynamic Therapy (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:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prasad Iyer, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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Participants were recruited from Mayo Clinic patients in Rochester, Minnesota who had undergone an ablation procedure for Barrett's Esophagus.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexlansoprazole | Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months dexlansoprazole: Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months |
| FG001 | Omeprazole | Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice. Omeprazole: Escalating doses of omeprazole (20-60 mg/day) for 6 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexlansoprazole | Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months dexlansoprazole: Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months |
| BG001 | Omeprazole |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Inflammation Biomarker Tissue PGE2 Level | Change from baseline in esophageal tissue biopsy prostaglandin E2 (PGE2) level, as determined by enzyme immunoassay | Posted | Mean | Standard Deviation | nanograms/gram of tissue | 3 months, 6 months |
|
Baseline to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexlansoprazole | Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months dexlansoprazole: Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prasad Iyer, MD | Mayo Clinic | 507-284-0970 | Iyer.Prasad@mayo.edu |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D001471 | Barrett Esophagus |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D064748 | Dexlansoprazole |
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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| Omeprazole | Drug | Escalating doses of omeprazole (20-60 mg/day) for 6 months |
|
|
Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.
Omeprazole: Escalating doses of omeprazole (20-60 mg/day) for 6 months
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| High Grade Dysplasia/Intramucosal Carcinoma | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/height in meters^2 |
|
| Barrett's Esophagus segment length, pre-ablation | Mean | Standard Deviation | cm |
|
| Diaphragmatic Hernia present | Number | Participants |
|
| Diaphragmatic Hernia length | Mean | Standard Deviation | cm |
|
| Number undergoing Endoscopic Mucosal Resection | Number | Participants |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | % of tubulin | 3 months, 6 months |
|
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Omeprazole | Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice. Omeprazole: Escalating doses of omeprazole (20-60 mg/day) for 6 months | 0 | 14 | 0 | 14 |
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| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| 0.64 |
| 2-Sided |
| No |
| Superiority or Other |