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Trial record 3 of 3 for:    "Barrett Esophagus" | "Lansoprazole"

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
Sponsor:
Information provided by (Responsible Party):
Prasad G. Iyer, Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Inflammation
Barrett's Esophagus
Interventions Drug: dexlansoprazole
Drug: Omeprazole
Enrollment 30
Recruitment Details Participants were recruited from Mayo Clinic patients in Rochester, Minnesota who had undergone an ablation procedure for Barrett's Esophagus.
Pre-assignment Details  
Arm/Group Title Dexlansoprazole Omeprazole
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 16 14
Completed 13 10
Not Completed 3 4
Reason Not Completed
Withdrawal by Subject             3             4
Arm/Group Title Dexlansoprazole Omeprazole Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 16 14 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 14 participants 30 participants
63.9  (6.9) 59.1  (8.9) 61.5  (8.14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 30 participants
Female
2
  12.5%
2
  14.3%
4
  13.3%
Male
14
  87.5%
12
  85.7%
26
  86.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 14 participants 30 participants
16 14 30
High Grade Dysplasia/Intramucosal Carcinoma  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 30 participants
Subjects with High-Grade Dysplasia/Carcinoma 12 10 22
Subjects with Low-Grade Dysplasia 4 4 8
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/height in meters^2
Number Analyzed 16 participants 14 participants 30 participants
30.9  (3.4) 29.3  (4.2) 30.14  (3.84)
Barrett's Esophagus segment length, pre-ablation  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 16 participants 14 participants 30 participants
5.3  (3.5) 4.8  (4.3) 5.06  (3.84)
Diaphragmatic Hernia present  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 30 participants
Subjects with Diaphragmatic Hernia 15 13 28
Subjects without Diaphragmatic Hernia 1 1 2
Diaphragmatic Hernia length  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 16 participants 14 participants 30 participants
3.6  (2.3) 3.0  (1.7) 3.3  (2.05)
Number undergoing Endoscopic Mucosal Resection  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants 14 participants 30 participants
Subjects undergoing resection 16 12 28
Subjects not undergoing resection 0 2 2
1.Primary Outcome
Title Change in Inflammation Biomarker Tissue PGE2 Level
Hide Description Change from baseline in esophageal tissue biopsy prostaglandin E2 (PGE2) level, as determined by enzyme immunoassay
Time Frame 3 months, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexlansoprazole Omeprazole
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: nanograms/gram of tissue
Change from baseline at 3 months 1.35  (3.16) -0.02  (1.47)
Change from baseline at 6 months 1.19  (3.58) -0.06  (1.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dexlansoprazole, Omeprazole
Comments Comparison between the two treatment groups at 3 months
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.30
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dexlansoprazole, Omeprazole
Comments Comparison between the two treatment groups at 6 months
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Change in Esophageal Inflammation Biomarker COX-2 Gene Expression
Hide Description Change from baseline in esophageal issue biopsy cyclooxygenase-2 (COX-2) gene expression, as determined by Western blot.
Time Frame 3 months, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexlansoprazole Omeprazole
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 16 14
Mean (Standard Deviation)
Unit of Measure: % of tubulin
Change from baseline at 3 months 36.81  (73.55) 27.17  (176.82)
Change from baseline at 6 months 56.54  (98.77) 25.49  (210.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dexlansoprazole, Omeprazole
Comments Comparison between the two treatment groups at 3 months
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dexlansoprazole
Comments Comparison between the two treatment groups at 6 months
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.64
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame Baseline to 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dexlansoprazole Omeprazole
Hide Arm/Group Description

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

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

All-Cause Mortality
Dexlansoprazole Omeprazole
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dexlansoprazole Omeprazole
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dexlansoprazole Omeprazole
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/14 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prasad Iyer, MD
Organization: Mayo Clinic
Phone: 507-284-0970
EMail: Iyer.Prasad@mayo.edu
Layout table for additonal information
Responsible Party: Prasad G. Iyer, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01093755     History of Changes
Other Study ID Numbers: 09-007252
First Submitted: March 24, 2010
First Posted: March 26, 2010
Results First Submitted: February 19, 2016
Results First Posted: March 17, 2016
Last Update Posted: March 17, 2016