Trial Outcomes & Findings for Esomeprazole Magnesium With or Without Aspirin in Preventing Esophageal Cancer in Patients With Barrett Esophagus (NCT NCT00474903)
NCT ID: NCT00474903
Last Updated: 2014-07-02
Results Overview
The mean tissue PGE2 is reported for each Arm.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
122 participants
Primary outcome timeframe
Baseline to 30 days after completion of study treatment
Results posted on
2014-07-02
Participant Flow
In total, 122 patients were randomized. Two patients withdrew due to an inadequate number of biopsies and a finding of high-grade dysplasia. Six participants were not evaluable for the primary endpoint due to sample-related issues (e.g., improper temperature, lost or delayed samples), leaving 114 evaluable participants for the primary endpoint.
Of the 120 participants in the intervention cohort, 114 were evaluable for the primary endpoint (n = 29, 42, and 43 in Arm I, Arm II, and Arm III, respectively).
Participant milestones
| Measure |
Arm I (Placebo, Esomeprazole Magnesium)
Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).
esomeprazole magnesium: Given orally placebo: Given orally
|
Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)
Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).
acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally
|
Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)
Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).
acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
47
|
45
|
|
Overall Study
COMPLETED
|
29
|
42
|
43
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
2
|
Reasons for withdrawal
| Measure |
Arm I (Placebo, Esomeprazole Magnesium)
Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).
esomeprazole magnesium: Given orally placebo: Given orally
|
Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)
Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).
acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally
|
Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)
Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).
acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
5
|
2
|
Baseline Characteristics
Esomeprazole Magnesium With or Without Aspirin in Preventing Esophageal Cancer in Patients With Barrett Esophagus
Baseline characteristics by cohort
| Measure |
Arm I (Placebo, Esomeprazole Magnesium)
n=30 Participants
Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).
esomeprazole magnesium: Given orally placebo: Given orally
|
Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)
n=45 Participants
Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).
acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally
|
Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)
n=45 Participants
Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).
acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
59 years
n=7 Participants
|
59 years
n=5 Participants
|
60 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
45 participants
n=7 Participants
|
45 participants
n=5 Participants
|
120 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to 30 days after completion of study treatmentThe mean tissue PGE2 is reported for each Arm.
Outcome measures
| Measure |
Arm I (Placebo, Esomeprazole Magnesium)
n=29 Participants
Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).
esomeprazole magnesium: Given orally placebo: Given orally
|
Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)
n=42 Participants
Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).
acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally
|
Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)
n=43 Participants
Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).
acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally
|
|---|---|---|---|
|
Change in Mean Tissue Prostaglandin E2 (PGE2) Concentration as Determined From Barrett's Research Mucosal Biopsy Samples
|
-67.6 pg/mL
Standard Deviation 229.68 • Interval -745.2 to 454.7
|
-123.9 pg/mL
Standard Deviation 284 • Interval -976.6 to 789.0
|
-174.9 pg/mL
Standard Deviation 263.62 • Interval -1113.6 to 75.3
|
SECONDARY outcome
Timeframe: Up to 30 days after completion of study treatmentPopulation: All 120 patients that took study medication were evaluable for this secondary endpoint.
Toxicity is defined as adverse events that are classified as either possibly, probably, or definitely related to the interventional agent, graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The number of patients reporting adverse events will be tabulated by grade.
Outcome measures
| Measure |
Arm I (Placebo, Esomeprazole Magnesium)
n=30 Participants
Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).
esomeprazole magnesium: Given orally placebo: Given orally
|
Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)
n=45 Participants
Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).
acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally
|
Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)
n=45 Participants
Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).
acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally
|
|---|---|---|---|
|
Toxicity
Grade 3 or Higher
|
0 participants
|
1 participants
|
1 participants
|
|
Toxicity
Grade 4 or Higher
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Arm I (Placebo, Esomeprazole Magnesium)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Placebo, Esomeprazole Magnesium)
n=30 participants at risk
Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).
esomeprazole magnesium: Given orally placebo: Given orally
|
Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)
n=45 participants at risk
Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).
acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally
|
Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)
n=45 participants at risk
Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).
acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally
|
|---|---|---|---|
|
Vascular disorders
Hypertension
|
0.00%
0/30
|
0.00%
0/45
|
2.2%
1/45 • Number of events 1
|
Other adverse events
| Measure |
Arm I (Placebo, Esomeprazole Magnesium)
n=30 participants at risk
Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).
esomeprazole magnesium: Given orally placebo: Given orally
|
Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)
n=45 participants at risk
Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).
acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally
|
Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)
n=45 participants at risk
Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).
acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Blood disorder
|
3.3%
1/30 • Number of events 1
|
0.00%
0/45
|
0.00%
0/45
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
3.3%
1/30 • Number of events 1
|
4.4%
2/45 • Number of events 3
|
0.00%
0/45
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/30
|
0.00%
0/45
|
2.2%
1/45 • Number of events 1
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/30
|
2.2%
1/45 • Number of events 1
|
0.00%
0/45
|
|
Gastrointestinal disorders
Abdominal distension
|
3.3%
1/30 • Number of events 1
|
0.00%
0/45
|
0.00%
0/45
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/30
|
2.2%
1/45 • Number of events 1
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Colonic hemorrhage
|
3.3%
1/30 • Number of events 1
|
0.00%
0/45
|
0.00%
0/45
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/30
|
2.2%
1/45 • Number of events 1
|
4.4%
2/45 • Number of events 2
|
|
Gastrointestinal disorders
Dyspepsia
|
3.3%
1/30 • Number of events 1
|
0.00%
0/45
|
8.9%
4/45 • Number of events 9
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/30
|
2.2%
1/45 • Number of events 1
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/30
|
0.00%
0/45
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
6.7%
2/30 • Number of events 12
|
0.00%
0/45
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
10.0%
3/30 • Number of events 3
|
2.2%
1/45 • Number of events 2
|
6.7%
3/45 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/30
|
2.2%
1/45 • Number of events 1
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/30
|
0.00%
0/45
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/30
|
2.2%
1/45 • Number of events 1
|
0.00%
0/45
|
|
General disorders
Chest pain
|
0.00%
0/30
|
0.00%
0/45
|
2.2%
1/45 • Number of events 2
|
|
General disorders
Fatigue
|
3.3%
1/30 • Number of events 1
|
0.00%
0/45
|
0.00%
0/45
|
|
General disorders
Flu-like symptoms
|
0.00%
0/30
|
0.00%
0/45
|
2.2%
1/45 • Number of events 1
|
|
General disorders
Pain
|
0.00%
0/30
|
2.2%
1/45 • Number of events 1
|
0.00%
0/45
|
|
Immune system disorders
Hypersensitivity
|
3.3%
1/30 • Number of events 1
|
0.00%
0/45
|
0.00%
0/45
|
|
Infections and infestations
Sinusitis
|
0.00%
0/30
|
2.2%
1/45 • Number of events 1
|
0.00%
0/45
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/30
|
0.00%
0/45
|
2.2%
1/45 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
3.3%
1/30 • Number of events 1
|
0.00%
0/45
|
0.00%
0/45
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
3.3%
1/30 • Number of events 1
|
0.00%
0/45
|
0.00%
0/45
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.3%
1/30 • Number of events 1
|
0.00%
0/45
|
0.00%
0/45
|
|
Nervous system disorders
Headache
|
0.00%
0/30
|
2.2%
1/45 • Number of events 1
|
0.00%
0/45
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/30
|
0.00%
0/45
|
2.2%
1/45 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage nasal
|
0.00%
0/30
|
0.00%
0/45
|
2.2%
1/45 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/30
|
0.00%
0/45
|
2.2%
1/45 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
3.3%
1/30 • Number of events 6
|
0.00%
0/45
|
0.00%
0/45
|
|
Vascular disorders
Hypotension
|
0.00%
0/30
|
0.00%
0/45
|
2.2%
1/45 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60