Trial Outcomes & Findings for Does Intensive Acid Suppression Reduce Esophageal Inflammation and Recurrent Barrett's Esophagus Following Ablation? (NCT NCT01093755)
NCT ID: NCT01093755
Last Updated: 2016-03-17
Results Overview
Change from baseline in esophageal tissue biopsy prostaglandin E2 (PGE2) level, as determined by enzyme immunoassay
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
3 months, 6 months
Results posted on
2016-03-17
Participant Flow
Participants were recruited from Mayo Clinic patients in Rochester, Minnesota who had undergone an ablation procedure for Barrett's Esophagus.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
14
|
|
Overall Study
COMPLETED
|
13
|
10
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
Baseline Characteristics
Does Intensive Acid Suppression Reduce Esophageal Inflammation and Recurrent Barrett's Esophagus Following Ablation?
Baseline characteristics by cohort
| Measure |
Dexlansoprazole
n=16 Participants
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
|
Omeprazole
n=14 Participants
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
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.9 Years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
59.1 Years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
61.5 Years
STANDARD_DEVIATION 8.14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
14 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
High Grade Dysplasia/Intramucosal Carcinoma
Subjects with High-Grade Dysplasia/Carcinoma
|
12 participants
n=5 Participants
|
10 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
High Grade Dysplasia/Intramucosal Carcinoma
Subjects with Low-Grade Dysplasia
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Body Mass Index
|
30.9 kg/height in meters^2
STANDARD_DEVIATION 3.4 • n=5 Participants
|
29.3 kg/height in meters^2
STANDARD_DEVIATION 4.2 • n=7 Participants
|
30.14 kg/height in meters^2
STANDARD_DEVIATION 3.84 • n=5 Participants
|
|
Barrett's Esophagus segment length, pre-ablation
|
5.3 cm
STANDARD_DEVIATION 3.5 • n=5 Participants
|
4.8 cm
STANDARD_DEVIATION 4.3 • n=7 Participants
|
5.06 cm
STANDARD_DEVIATION 3.84 • n=5 Participants
|
|
Diaphragmatic Hernia present
Subjects with Diaphragmatic Hernia
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Diaphragmatic Hernia present
Subjects without Diaphragmatic Hernia
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Diaphragmatic Hernia length
|
3.6 cm
STANDARD_DEVIATION 2.3 • n=5 Participants
|
3.0 cm
STANDARD_DEVIATION 1.7 • n=7 Participants
|
3.3 cm
STANDARD_DEVIATION 2.05 • n=5 Participants
|
|
Number undergoing Endoscopic Mucosal Resection
Subjects undergoing resection
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Number undergoing Endoscopic Mucosal Resection
Subjects not undergoing resection
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months, 6 monthsChange from baseline in esophageal tissue biopsy prostaglandin E2 (PGE2) level, as determined by enzyme immunoassay
Outcome measures
| Measure |
Dexlansoprazole
n=16 Participants
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
|
Omeprazole
n=14 Participants
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
|
|---|---|---|
|
Change in Inflammation Biomarker Tissue PGE2 Level
Change from baseline at 3 months
|
1.35 nanograms/gram of tissue
Standard Deviation 3.16
|
-0.02 nanograms/gram of tissue
Standard Deviation 1.47
|
|
Change in Inflammation Biomarker Tissue PGE2 Level
Change from baseline at 6 months
|
1.19 nanograms/gram of tissue
Standard Deviation 3.58
|
-0.06 nanograms/gram of tissue
Standard Deviation 1.45
|
PRIMARY outcome
Timeframe: 3 months, 6 monthsChange from baseline in esophageal issue biopsy cyclooxygenase-2 (COX-2) gene expression, as determined by Western blot.
Outcome measures
| Measure |
Dexlansoprazole
n=16 Participants
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
|
Omeprazole
n=14 Participants
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
|
|---|---|---|
|
Change in Esophageal Inflammation Biomarker COX-2 Gene Expression
Change from baseline at 3 months
|
36.81 % of tubulin
Standard Deviation 73.55
|
27.17 % of tubulin
Standard Deviation 176.82
|
|
Change in Esophageal Inflammation Biomarker COX-2 Gene Expression
Change from baseline at 6 months
|
56.54 % of tubulin
Standard Deviation 98.77
|
25.49 % of tubulin
Standard Deviation 210.67
|
Adverse Events
Dexlansoprazole
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Omeprazole
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place