Trial Outcomes & Findings for Aspirin in Preventing Disease Recurrence in Patients With Barrett Esophagus After Successful Elimination by Radiofrequency Ablation (NCT NCT02521285)

Last Updated: 2025-10-23

Results Overview

Measured the absolute and relative values in percentage of biomarker levels CDX2 mRNA levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location A (1 cm above GE Junction.) The difference in the change were measured by the total RNAs were isolated from squamous and neosquamous mucosal biopsy specimens using Trizol and quantitated by spectrophotometry.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

Baseline and 12 months

Results posted on

2025-10-23

Participant Flow

21 participants were randomized due to 12 were unevaluable.

Participant milestones

Participant milestones
Measure	Arm A (Aspirin) Participants received aspirin 325 mg orally (PO) once daily for 12 months	Arm B (Placebo) Participants received placebo daily
Overall Study STARTED	10	11
Overall Study COMPLETED	8	8
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A (Aspirin) Participants received aspirin 325 mg orally (PO) once daily for 12 months	Arm B (Placebo) Participants received placebo daily
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	1	1
Overall Study Adverse Event	0	1

Baseline Characteristics

Aspirin in Preventing Disease Recurrence in Patients With Barrett Esophagus After Successful Elimination by Radiofrequency Ablation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A (Aspirin) n=10 Participants Participants received aspirin 325 mg orally (PO) once daily for 12 months	Arm B (Placebo) n=11 Participants Participants received placebo daily	Total n=21 Participants Total of all reporting groups
Race (NIH/OMB) White	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Age, Continuous	64.5 years n=5 Participants	67 years n=7 Participants	67 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	11 participants n=7 Participants	21 participants n=5 Participants
Baseline cdx2/normalized to GAPDH	0.34 percentage of biomarker levels n=5 Participants	0.438 percentage of biomarker levels n=7 Participants	0.384 percentage of biomarker levels n=5 Participants
Baseline p-p65/total p65 corrected for tubulin	0.484 percentage of biomarker levels n=5 Participants	0.624 percentage of biomarker levels n=7 Participants	0.484 percentage of biomarker levels n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 months

Population: 1 participant withdrew consent and decided to take a baby aspirin, per PCP recommendation in the Aspirin arm and 1 participant was lost to follow up, 1 participant withdrew consent, and 1 participant adverse event in the Placebo arm

Outcome measures

Outcome measures
Measure	Arm A (Aspirin) n=7 Participants Participants received aspirin 325 mg orally (PO) once daily for 12 months	Arm B (Placebo) n=5 Participants Participants received placebo daily
Difference in the Change of CDX2 mRNA Levels in Esophageal Mucosa Between Participants Taking Aspirin and Placebo at 12 Months (Location A) 12 month (Absolute)	0.01 change of percentage of CDX2 mRNA levels Interval -0.82 to 0.82	-0.1 change of percentage of CDX2 mRNA levels Interval -0.57 to 0.0
Difference in the Change of CDX2 mRNA Levels in Esophageal Mucosa Between Participants Taking Aspirin and Placebo at 12 Months (Location A) 12 month (Relative)	0.05 change of percentage of CDX2 mRNA levels Interval -0.94 to 2.34	-0.87 change of percentage of CDX2 mRNA levels Interval -0.99 to -0.23

PRIMARY outcome

Timeframe: Baseline and 12 months

Measured the absolute and relative values change in the biomarker levels CDX2 mRNA levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment). The difference in the change were measured by the total RNAs were isolated from squamous and neosquamous mucosal biopsy specimens using Trizol and quantitated by spectrophotometry.

Outcome measures

Outcome measures
Measure	Arm A (Aspirin) n=8 Participants Participants received aspirin 325 mg orally (PO) once daily for 12 months	Arm B (Placebo) n=8 Participants Participants received placebo daily
Differences in the Change of CDX2 Messenger Ribonucleic Acid (mRNA) Levels in Esophageal Squamous Tissue Between Participants Taking Aspirin Supplementation Versus Those Taking Placebo (Location B) 12 month change (Absolute)	-0.18 change of percentage of CDX2 mRNA levels Interval -0.6 to 0.0	-0.17 change of percentage of CDX2 mRNA levels Interval -4.43 to 0.62
Differences in the Change of CDX2 Messenger Ribonucleic Acid (mRNA) Levels in Esophageal Squamous Tissue Between Participants Taking Aspirin Supplementation Versus Those Taking Placebo (Location B) 12 month change (Relative)	-0.7 change of percentage of CDX2 mRNA levels Interval -0.9 to -0.25	-0.6 change of percentage of CDX2 mRNA levels Interval -1.0 to 9.76

PRIMARY outcome

Timeframe: Baseline and 12 months

Measured the absolute and relative values change in the biomarker levels CDX2 mRNA levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment). The difference in the change were measured by the total RNAs were isolated from squamous and neosquamous mucosal biopsy specimens using Trizol and quantitated by spectrophotometry.

Outcome measures

Outcome measures
Measure	Arm A (Aspirin) n=8 Participants Participants received aspirin 325 mg orally (PO) once daily for 12 months	Arm B (Placebo) n=8 Participants Participants received placebo daily
Differences in the Change of CDX2 Messenger Ribonucleic Acid (mRNA) Levels in Esophageal Squamous Tissue Between Participants Taking Aspirin Supplementation Versus Those Taking Placebo ( Location C) 12 month change (Absolute)	-0.25 change of percentage of CDX2 mRNA levels Interval -1.04 to 0.04	-0.17 change of percentage of CDX2 mRNA levels Interval -0.82 to 0.52
Differences in the Change of CDX2 Messenger Ribonucleic Acid (mRNA) Levels in Esophageal Squamous Tissue Between Participants Taking Aspirin Supplementation Versus Those Taking Placebo ( Location C) 12 month change (Relative)	-0.98 change of percentage of CDX2 mRNA levels Interval -1.0 to 0.95	-0.51 change of percentage of CDX2 mRNA levels Interval -0.9 to 1.45

PRIMARY outcome

Timeframe: Baseline and 12 months

Measured the absolute and relative values change in the biomarker levels p-p65/total p65 in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location A, 1 cm above GE Junction. The difference in the change were measured by using esophageal squamous and neosquamous mucosal biopsies taken before and after treatment with aspirin, levels of phospho-p65 and total p65 were determined by Western blot and quantitated by densitometry.

Outcome measures

Outcome measures
Measure	Arm A (Aspirin) n=7 Participants Participants received aspirin 325 mg orally (PO) once daily for 12 months	Arm B (Placebo) n=5 Participants Participants received placebo daily
Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 12 Months (Location A) 12 month change (Absolute)	0.16 change of % of p-p65/total p65 levels Interval -0.43 to 1.38	0.16 change of % of p-p65/total p65 levels Interval -1.89 to 0.37
Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 12 Months (Location A) 12 month change (Relative)	0.26 change of % of p-p65/total p65 levels Interval -0.65 to 13.17	0.84 change of % of p-p65/total p65 levels Interval -0.8 to 32.08

PRIMARY outcome

Timeframe: Baseline and 12 months

Measured the absolute and relative values change in the biomarker levels p-p65/total p65 in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment)The difference in the change were measured by using esophageal squamous and neosquamous mucosal biopsies taken before and after treatment with aspirin, levels of phospho-p65 and total p65 were determined by Western blot and quantitated by densitometry.

Outcome measures

Outcome measures
Measure	Arm A (Aspirin) n=8 Participants Participants received aspirin 325 mg orally (PO) once daily for 12 months	Arm B (Placebo) n=8 Participants Participants received placebo daily
Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 12 Months (Location B) 12 month change (Absolute)	-0.12 change of % of p-p65/total p65 levels Interval -0.4 to 1.26	-0.32 change of % of p-p65/total p65 levels Interval -1.15 to 0.3
Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 12 Months (Location B) 12month change (Relative)	-0.37 change of % of p-p65/total p65 levels Interval -0.82 to 13.37	-0.57 change of % of p-p65/total p65 levels Interval -0.95 to 2.8

PRIMARY outcome

Timeframe: Baseline and 12 months

Measured the absolute and relative values change in the biomarker levels p-p65/total p65 in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment). The difference in the change were measured by using esophageal squamous and neosquamous mucosal biopsies taken before and after treatment with aspirin, levels of phospho-p65 and total p65 were determined by Western blot and quantitated by densitometry.

Outcome measures

Outcome measures
Measure	Arm A (Aspirin) n=8 Participants Participants received aspirin 325 mg orally (PO) once daily for 12 months	Arm B (Placebo) n=8 Participants Participants received placebo daily
Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 12 Months (Location C) 12month change (Relative)	-0.53 change of % of p-p65/total p65 levels Interval -0.77 to 2.56	-0.6 change of % of p-p65/total p65 levels Interval -0.88 to 0.2
Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 12 Months (Location C) 12 month change (Absolute)	-0.37 change of % of p-p65/total p65 levels Interval -0.76 to 0.15	-0.28 change of % of p-p65/total p65 levels Interval -0.83 to 0.23

SECONDARY outcome

Timeframe: Up to 18 months

Number of Participants experiencing adverse events by maximum grade (grades 1-3). Safety assessed by comparison of adverse events using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. AEs will be assessed according to the CTCAE grade associated with the AE term. All adverse events are listed in the Adverse Events Overview.

Outcome measures

Outcome measures
Measure	Arm A (Aspirin) n=8 Participants Participants received aspirin 325 mg orally (PO) once daily for 12 months	Arm B (Placebo) n=8 Participants Participants received placebo daily
Number of Participants With Adverse Events (AE) Adverse Event Grade 1	5 Participants	5 Participants
Number of Participants With Adverse Events (AE) Adverse Event Grade 2	2 Participants	5 Participants
Number of Participants With Adverse Events (AE) Adverse Event Grade 3	5 Participants	3 Participants

SECONDARY outcome

Timeframe: Baseline to 18 months

Measured the change in the biomarker levels CDX2 mRNA levels in esophageal mucosa at baseline and 18 months for each participant taking aspirin versus placebo at Location A, 1 cm above GE Junction. The difference in the change were measured by the total RNAs will be isolated from squamous and neosquamous mucosal biopsy specimens using Trizol and quantitated by spectrophotometry.

Outcome measures

Outcome measures
Measure	Arm A (Aspirin) n=3 Participants Participants received aspirin 325 mg orally (PO) once daily for 12 months	Arm B (Placebo) n=1 Participants Participants received placebo daily
Differences in the Change of CDX2 mRNA Levels in Esophageal Squamous Tissue Between Participants Taking Aspirin Supplementation Versus Those Taking Placebo at 18 Months (Location A)	-56 percentage of biomarkers level Interval -86.0 to 122.0	58 percentage of biomarkers level Interval -86.0 to 122.0

SECONDARY outcome

Timeframe: Up to 18 months

Measured change in the biomarker levels CDX2 mRNA levels in esophageal mucosa at baseline and 18 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment). The difference in the change were measured by the total RNAs will be isolated from squamous and neosquamous mucosal biopsy specimens using Trizol and quantitated by spectrophotometry.

Outcome measures

Outcome measures
Measure	Arm A (Aspirin) n=4 Participants Participants received aspirin 325 mg orally (PO) once daily for 12 months	Arm B (Placebo) n=1 Participants Participants received placebo daily
Differences in the Change of CDX2 mRNA Levels in Esophageal Squamous Tissue Between Participants Taking Aspirin Supplementation Versus Those Taking Placebo at 18 Months (Location B)	-45 percentage of biomarkers level Interval -99.0 to 1218.0	-74 percentage of biomarkers level Interval -99.0 to 1218.0

SECONDARY outcome

Timeframe: Baseline to 18 months

Measured the change in the biomarker levels CDX2 mRNA levels in esophageal mucosa at baseline and 18 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment). The difference in the change were measured by the total RNAs will be isolated from squamous and neosquamous mucosal biopsy specimens using Trizol and quantitated by spectrophotometry.

Outcome measures

Outcome measures
Measure	Arm A (Aspirin) n=4 Participants Participants received aspirin 325 mg orally (PO) once daily for 12 months	Arm B (Placebo) n=1 Participants Participants received placebo daily
Differences in the Change of CDX2 mRNA Levels in Esophageal Squamous Tissue Between Participants Taking Aspirin Supplementation Versus Those Taking Placebo at 18 Months (Location C)	-93 percentage of biomarkers level Interval -99.0 to -43.0	-53 percentage of biomarkers level Interval -99.0 to -43.0

SECONDARY outcome

Timeframe: Baseline up to 18 months

Population: Participants with biopsies available at 18-months.

Measured the change in the biomarker levels p-p65/total p65 in the esophageal mucosa at baseline and 18 months for each participant taking aspirin versus placebo at Location A, 1 cm above GE Junction. The difference in the change were measured by using esophageal squamous and neosquamous mucosal biopsies taken before and after treatment with aspirin, levels of phospho-p65 and total p65 were determined by Western blot and quantitated by densitometry.

Outcome measures

Outcome measures
Measure	Arm A (Aspirin) n=3 Participants Participants received aspirin 325 mg orally (PO) once daily for 12 months	Arm B (Placebo) n=1 Participants Participants received placebo daily
Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 18 Months (Location A)	-71 percentage of biomarkers level Interval -94.0 to 1.0	.113 percentage of biomarkers level Interval -94.0 to 1.0

SECONDARY outcome

Timeframe: Baseline up to 18 months

Measured the change in the biomarker levels of p-p65/total p65 in the esophageal mucosa at baseline and 18 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment). The difference in the change were measured by using esophageal squamous and neosquamous mucosal biopsies taken before and after treatment with aspirin, levels of phospho-p65 and total p65 were determined by Western blot and quantitated by densitometry.

Outcome measures

Outcome measures
Measure	Arm A (Aspirin) n=4 Participants Participants received aspirin 325 mg orally (PO) once daily for 12 months	Arm B (Placebo) n=1 Participants Participants received placebo daily
Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 18 Months (Location B)	-59 percentage of biomarkers level Interval -91.0 to 1643.0	393 percentage of biomarkers level Interval -91.0 to 1643.0

SECONDARY outcome

Timeframe: Baseline up to 18 months

Measured the change in the biomarker levels p-p65/total p65 in esophageal mucosa at baseline and 18 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment). The difference in the change were measured by using esophageal squamous and neosquamous mucosal biopsies taken before and after treatment with aspirin, levels of phospho-p65 and total p65 were determined by Western blot and quantitated by densitometry.

Outcome measures

Outcome measures
Measure	Arm A (Aspirin) n=4 Participants Participants received aspirin 325 mg orally (PO) once daily for 12 months	Arm B (Placebo) n=1 Participants Participants received placebo daily
Differences in the Activation Status of NF-kB by Assessing Levels of Total and Phospho-p65 and Cytoplasmic to Nuclear Translocation of Phospho-p65 at 18 Months (Location C)	-29 percentage of biomarkers level Interval -64.0 to 16.0	.37 percentage of biomarkers level Interval -64.0 to 16.0

SECONDARY outcome

Timeframe: Baseline and 12 months

Measured the absolute and relative values change in the biomarker levels txb2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location A, 1 cm above GE Junction. The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses.

Outcome measures

Outcome measures
Measure	Arm A (Aspirin) n=7 Participants Participants received aspirin 325 mg orally (PO) once daily for 12 months	Arm B (Placebo) n=5 Participants Participants received placebo daily
Differences in the Change of txb2 at 12 Months (Location A) 12 month change (Absolute)	-2.07 change of percentage of txb2 levels Interval -8.48 to 2.33	-1.07 change of percentage of txb2 levels Interval -51.57 to 3.27
Differences in the Change of txb2 at 12 Months (Location A) 12 month change (Relative)	-0.61 change of percentage of txb2 levels Interval -0.94 to 1.98	-0.73 change of percentage of txb2 levels Interval -99.0 to 206.0

SECONDARY outcome

Timeframe: Baseline and 12 months

Measured the absolute and relative values change in the biomarker levels txb2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses.

Outcome measures

Outcome measures
Measure	Arm A (Aspirin) n=7 Participants Participants received aspirin 325 mg orally (PO) once daily for 12 months	Arm B (Placebo) n=8 Participants Participants received placebo daily
Differences in the Change of tbx2 at 12 Months (Location B) 12 month change (Absolute)	-2.33 change of percentage of tbx2 levels Interval -52.34 to 0.81	-0.19 change of percentage of tbx2 levels Interval -46.98 to 2.52
Differences in the Change of tbx2 at 12 Months (Location B) 12 month change (Relative)	-0.69 change of percentage of tbx2 levels Interval -1.0 to 0.7	0.76 change of percentage of tbx2 levels Interval -1.0 to 4.81

SECONDARY outcome

Timeframe: Baseline and 12 months

Measured the absolute and relative values change in the biomarker levels txb2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses.

Outcome measures

Outcome measures
Measure	Arm A (Aspirin) n=8 Participants Participants received aspirin 325 mg orally (PO) once daily for 12 months	Arm B (Placebo) n=8 Participants Participants received placebo daily
Differences in the Change of tbx2 at 12 Months (Location C) 12 month change (Absolute)	-3.58 change of percentage of tbx2 levels Interval -16.26 to 1.05	0.5 change of percentage of tbx2 levels Interval -30.48 to 5.55
Differences in the Change of tbx2 at 12 Months (Location C) 12 month change (Relative)	-0.81 change of percentage of tbx2 levels Interval -1.0 to 1.09	1.18 change of percentage of tbx2 levels Interval -1.0 to 3.94

SECONDARY outcome

Timeframe: Baseline and 12 months

Measured the absolute and relative values change in the biomarker levels pge1 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at A (1 cm above GE Junction). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses.

Outcome measures

Outcome measures
Measure	Arm A (Aspirin) n=7 Participants Participants received aspirin 325 mg orally (PO) once daily for 12 months	Arm B (Placebo) n=5 Participants Participants received placebo daily
Differences in the Change of pge1 at 12 Months ( Location A) 12 month change (Absolute)	-2.29 change of percentage of pge1 levels Interval -16.39 to 2.52	-1.13 change of percentage of pge1 levels Interval -44.74 to 2.95
Differences in the Change of pge1 at 12 Months ( Location A) 12 month change (Relative)	-0.52 change of percentage of pge1 levels Interval -0.98 to 2.21	-0.87 change of percentage of pge1 levels Interval -1.0 to 1.1

SECONDARY outcome

Timeframe: Baseline and 12 months

Measured the absolute and relative values change in the biomarker levels pge1 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses.

Outcome measures

Outcome measures
Measure	Arm A (Aspirin) n=7 Participants Participants received aspirin 325 mg orally (PO) once daily for 12 months	Arm B (Placebo) n=8 Participants Participants received placebo daily
Differences in the Change of pge1 at 12 Months (Location B) 12 month change (Absolute)	-7.22 change of percentage of pge1 levels Interval -13.63 to 1.12	-0.08 change of percentage of pge1 levels Interval -17.61 to 1.65
Differences in the Change of pge1 at 12 Months (Location B) 12 month change (Relative)	-0.73 change of percentage of pge1 levels Interval -0.95 to 0.72	-0.19 change of percentage of pge1 levels Interval -0.97 to 0.62

SECONDARY outcome

Timeframe: Baseline and 12 months

Measured the absolute and relative values change in the biomarker levels pge1 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses.

Outcome measures

Outcome measures
Measure	Arm A (Aspirin) n=8 Participants Participants received aspirin 325 mg orally (PO) once daily for 12 months	Arm B (Placebo) n=8 Participants Participants received placebo daily
Differences in the Change of pge1 at 12 Months (Location C) 12 month change (Absolute)	-7.79 change of percentage of pge1 levels Interval -40.65 to 7.99	2.71 change of percentage of pge1 levels Interval -19.72 to 18.54
Differences in the Change of pge1 at 12 Months (Location C) 12 month change (Relative)	-0.75 change of percentage of pge1 levels Interval -0.9 to 13.43	2.48 change of percentage of pge1 levels Interval -0.95 to 11.59

SECONDARY outcome

Timeframe: Baseline and 12 months

Measured the absolute and relative values change in the biomarker levels pge2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at A (1 cm above GE Junction). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses.

Outcome measures

Outcome measures
Measure	Arm A (Aspirin) n=7 Participants Participants received aspirin 325 mg orally (PO) once daily for 12 months	Arm B (Placebo) n=5 Participants Participants received placebo daily
Differences in the Change of pge2 at 12 Months (Location A) 12 month change (Relative)	-0.24 change of percentage of pge2 levels Interval -0.96 to 1.83	-0.78 change of percentage of pge2 levels Interval -0.92 to 0.58
Differences in the Change of pge2 at 12 Months (Location A) 12 month change (Absolute)	-6.77 change of percentage of pge2 levels Interval -38.18 to 8.53	-5.13 change of percentage of pge2 levels Interval -110.54 to 6.57

SECONDARY outcome

Timeframe: Baseline and 12 months

Measured the absolute and relative values change in the biomarker levels pge2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses.

Outcome measures

Outcome measures
Measure	Arm A (Aspirin) n=7 Participants Participants received aspirin 325 mg orally (PO) once daily for 12 months	Arm B (Placebo) n=8 Participants Participants received placebo daily
Differences in the Change of pge2 at 12 Months (Location B) 12 month change (Absolute)	-20.53 change of percentage of pge2 levels Interval -71.98 to 2.46	-11 change of percentage of pge2 levels Interval -59.68 to 8.71
Differences in the Change of pge2 at 12 Months (Location B) 12 month change (Relative)	-0.74 change of percentage of pge2 levels Interval -0.95 to 0.27	-0.51 change of percentage of pge2 levels Interval -0.95 to 1.08

SECONDARY outcome

Timeframe: Baseline and 12 months

Measured the absolute and relative values change in the biomarker levels pge2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses.

Outcome measures

Outcome measures
Measure	Arm A (Aspirin) n=8 Participants Participants received aspirin 325 mg orally (PO) once daily for 12 months	Arm B (Placebo) n=8 Participants Participants received placebo daily
Differences in the Change in pge2 at 12 Months (Location C) 12 month change (Absolute)	-19.23 change of percentage of pge2 levels Interval -85.32 to 19.03	9.94 change of percentage of pge2 levels Interval -155.89 to 43.35
Differences in the Change in pge2 at 12 Months (Location C) 12 month change (Relative)	-0.7 change of percentage of pge2 levels Interval -0.95 to 5.27	1.96 change of percentage of pge2 levels Interval -0.98 to 10.28

SECONDARY outcome

Timeframe: Baseline and 12 months

Measured the absolute and relative values change in the biomarker levels a13pge1 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location A (1 cm above GE Junction). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses.

Outcome measures

Outcome measures
Measure	Arm A (Aspirin) n=7 Participants Participants received aspirin 325 mg orally (PO) once daily for 12 months	Arm B (Placebo) n=5 Participants Participants received placebo daily
Differences in the Change of a13pge1 at 12 Months (Location A) Absolute Value	-0.29 change of percentage of a13pge1 levels Interval -7.05 to 0.93	0 change of percentage of a13pge1 levels Interval -5.78 to 4.38
Differences in the Change of a13pge1 at 12 Months (Location A) Relative Value	-99 change of percentage of a13pge1 levels Interval -100.0 to -83.0	-93 change of percentage of a13pge1 levels Interval -100.0 to -86.0

SECONDARY outcome

Timeframe: Baseline and 12 months

Measured the absolute and relative values change in the biomarker levels a13pge1 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses.

Outcome measures

Outcome measures
Measure	Arm A (Aspirin) n=7 Participants Participants received aspirin 325 mg orally (PO) once daily for 12 months	Arm B (Placebo) n=8 Participants Participants received placebo daily
Differences in the Change of a13pge1 at 12 Months ( Location B) 12 month change (Absolute)	-1.62 change of percentage of a13pge1 levels Interval -10.32 to 0.0	0.19 change of percentage of a13pge1 levels Interval -6.51 to 0.72
Differences in the Change of a13pge1 at 12 Months ( Location B) 12 month change (Relative)	-92 change of percentage of a13pge1 levels Interval -100.0 to -74.0	-65 change of percentage of a13pge1 levels Interval -65.0 to -65.0

SECONDARY outcome

Timeframe: Baseline and 12 months

Measured the absolute and relative values change in the biomarker levels a13pge1 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses.

Outcome measures

Outcome measures
Measure	Arm A (Aspirin) n=8 Participants Participants received aspirin 325 mg orally (PO) once daily for 12 months	Arm B (Placebo) n=8 Participants Participants received placebo daily
Differences in the Change in a13pge1 at 12 Months (Location C) 12 month change (Absolute)	0 change of percentage of a13pge1 levels Interval -3.4 to 0.75	0 change of percentage of a13pge1 levels Interval -3.83 to 1.01
Differences in the Change in a13pge1 at 12 Months (Location C) 12 month change (Relative	-61 change of percentage of a13pge1 levels Interval -100.0 to 200.0	-100 change of percentage of a13pge1 levels Interval -100.0 to -100.0

SECONDARY outcome

Timeframe: Baseline and 12 months

Measured the absolute and relative values change in the biomarker levels a13pge2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location A (1 cm above GE Junction). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses.

Outcome measures

Outcome measures
Measure	Arm A (Aspirin) n=7 Participants Participants received aspirin 325 mg orally (PO) once daily for 12 months	Arm B (Placebo) n=5 Participants Participants received placebo daily
Differences in the Change of a13pge2 at 12 Months (Location A) 12 month change (Absolute)	-4.25 change of percentage of a13pge2 levels Interval -19.76 to 1.79	-2.23 change of percentage of a13pge2 levels Interval -215.45 to 22.72
Differences in the Change of a13pge2 at 12 Months (Location A) 12 month change (Relative)	-0.93 change of percentage of a13pge2 levels Interval -1.0 to 1.05	-0.8 change of percentage of a13pge2 levels Interval -1.0 to 7.43

SECONDARY outcome

Timeframe: Baseline and 12 months

Measured the absolute and relative values change in the biomarker levels a13pge2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location B (middle of former Barrett's segment). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses.

Outcome measures

Outcome measures
Measure	Arm A (Aspirin) n=7 Participants Participants received aspirin 325 mg orally (PO) once daily for 12 months	Arm B (Placebo) n=8 Participants Participants received placebo daily
Differences in the Change of a13pge2 at 12month (Location B) 12 month change (Relative)	-0.89 change of percentage of a13pge2 levels Interval -0.98 to 0.86	-0.73 change of percentage of a13pge2 levels Interval -0.99 to 1.05
Differences in the Change of a13pge2 at 12month (Location B) 12 month change (Absolute)	-13.94 change of percentage of a13pge2 levels Interval -85.07 to 0.82	-5.56 change of percentage of a13pge2 levels Interval -169.75 to 2.8

SECONDARY outcome

Timeframe: Baseline and 12 months

Measured the absolute and relative values change in the biomarker levels a13pge2 levels in the esophageal mucosa at baseline and 12 months for each participant taking aspirin versus placebo at Location C (2 cm above former Barrett's segment). The difference in the change were measured by the Liquid chromatography-mass spectrometry (LC/MS/MS) analyses.

Outcome measures

Outcome measures
Measure	Arm A (Aspirin) n=8 Participants Participants received aspirin 325 mg orally (PO) once daily for 12 months	Arm B (Placebo) n=8 Participants Participants received placebo daily
Differences in the Change of a13pge2 at 12 Months (Location C) 12 month change (Absolute)	-8.18 percentage of a13pge2 biomarkers level Interval -31.56 to 2.42	2.78 percentage of a13pge2 biomarkers level Interval -87.29 to 25.17
Differences in the Change of a13pge2 at 12 Months (Location C) 12 month change (Relative)	-0.51 percentage of a13pge2 biomarkers level Interval -1.0 to 5.57	2.27 percentage of a13pge2 biomarkers level Interval -0.98 to 11.22

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 18 months

Listed separately as #7-13 Secondary Outcome Measures.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 18 months

Population: Differences in the Expression of Proinflammatory Cytokines (a secondary endpoint) was not measured as there was insufficient biopsy material to perform these measurements. Alternatively we measured multiple additional prostaglandins and downstream markers as secondary endpoints since we were able to use smaller amounts of sample on a platform which allowed multiple measurements. These results are detailed in section which lists prostanoid measurements.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline up to 18 months

Outcome measures

Outcome data not reported

Adverse Events

Arm A (Aspirin)

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Arm B (Placebo)

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A (Aspirin) n=8 participants at risk Participants receive aspirin orally (PO) once daily (QD) for 12 months	Arm B (Placebo) n=8 participants at risk Participants received placebo daily
Vascular disorders Subdural Hematoma	0.00% 0/8 • baseline and at each visit throughout the trial (including Month 1, every 3 months by phone calls and/or mail interviews and in person at 12 and 18 months), and by monitoring laboratory parameters at baseline and at 12 months.	12.5% 1/8 • baseline and at each visit throughout the trial (including Month 1, every 3 months by phone calls and/or mail interviews and in person at 12 and 18 months), and by monitoring laboratory parameters at baseline and at 12 months.
Surgical and medical procedures Drainage of Subdural Hematoma	0.00% 0/8 • baseline and at each visit throughout the trial (including Month 1, every 3 months by phone calls and/or mail interviews and in person at 12 and 18 months), and by monitoring laboratory parameters at baseline and at 12 months.	12.5% 1/8 • baseline and at each visit throughout the trial (including Month 1, every 3 months by phone calls and/or mail interviews and in person at 12 and 18 months), and by monitoring laboratory parameters at baseline and at 12 months.
Surgical and medical procedures Parotidectomy	12.5% 1/8 • baseline and at each visit throughout the trial (including Month 1, every 3 months by phone calls and/or mail interviews and in person at 12 and 18 months), and by monitoring laboratory parameters at baseline and at 12 months.	0.00% 0/8 • baseline and at each visit throughout the trial (including Month 1, every 3 months by phone calls and/or mail interviews and in person at 12 and 18 months), and by monitoring laboratory parameters at baseline and at 12 months.
Gastrointestinal disorders Small Bowel Obstruction	12.5% 1/8 • baseline and at each visit throughout the trial (including Month 1, every 3 months by phone calls and/or mail interviews and in person at 12 and 18 months), and by monitoring laboratory parameters at baseline and at 12 months.	0.00% 0/8 • baseline and at each visit throughout the trial (including Month 1, every 3 months by phone calls and/or mail interviews and in person at 12 and 18 months), and by monitoring laboratory parameters at baseline and at 12 months.
Musculoskeletal and connective tissue disorders Severe Stenosis	0.00% 0/8 • baseline and at each visit throughout the trial (including Month 1, every 3 months by phone calls and/or mail interviews and in person at 12 and 18 months), and by monitoring laboratory parameters at baseline and at 12 months.	12.5% 1/8 • baseline and at each visit throughout the trial (including Month 1, every 3 months by phone calls and/or mail interviews and in person at 12 and 18 months), and by monitoring laboratory parameters at baseline and at 12 months.
Surgical and medical procedures Hiatus Hernia Repair	12.5% 1/8 • baseline and at each visit throughout the trial (including Month 1, every 3 months by phone calls and/or mail interviews and in person at 12 and 18 months), and by monitoring laboratory parameters at baseline and at 12 months.	0.00% 0/8 • baseline and at each visit throughout the trial (including Month 1, every 3 months by phone calls and/or mail interviews and in person at 12 and 18 months), and by monitoring laboratory parameters at baseline and at 12 months.

Other adverse events

Additional Information

Robert S. Bresalier, MD- Professor, Gastroenterology Hepat & Nutr

UT MD Anderson Cancer Center

Phone: (713) 745-4340

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60