Back to resultsBarrett's Esophagus - 315 - 3 Way Cross Over
Primary Purpose
Barrett's Esophagus
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Esomeprazole
Aspirin
Rofecoxib
Sponsored by
About this trial
This is an interventional treatment trial for Barrett's Esophagus focused on measuring Barrett's Esophagus, Nexium
Eligibility Criteria
Inclusion Criteria:
- A biopsy-proven diagnosis of Barrett's esophagus segment length greater than 2cm with no dysplasia or adenocarcinoma.
- Clinically normal laboratory results and physical findings at screening.
Exclusion Criteria:
- A history of esophageal, gastric or duodenal surgery, including antireflux surgery or endoscopic antireflux procedures, except for simple closure of an ulcer.
- Evidence of the following diseases or conditions:
- Barrett's esophagus less than or greater than 2cm that is positive for high grade dysplasia or adenocarcinoma
- Signs and symptoms of gastric outlet obstruction
- Active peptic ulcer disease
- severe liver disease
- Pancreatitis
- Malabsorption
- Active inflammatory bowel disease
- Severe pulmonary, cardiovascular or renal disease
- Impaired renal function or abnormal urine sediment on repeated examinations
- esophageal stricture or active, severe esophagitis.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
1
2
3
4
Arm Description
Nexium 40mg
Nexium 40mg + aspirin
Nexium 40mg + Rofecoxib 25 mg
Rofecoxib 25mg
Outcomes
Primary Outcome Measures
Measure PGE production in Barrett's metastatic tissue & determine the reduction from baseline of PGE production would be equivalent on Day 10 in esomeprazole 40mg bid + aspirin treatment compared to esomeprazole 40 mg bid + rofecoxib 25 mg qd treatment
Secondary Outcome Measures
To determine in which of the four treatment groups the reduction in the baseline in PGE2 production, COX-2 enzyme activity and PCNA expression in Barrett's metaplastic tissue is the greatest.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00637988
Brief Title
Barrett's Esophagus - 315 - 3 Way Cross Over
Official Title
A Multicenter, Open-label, Four-way Crossover Study of the Effects of Esomeprazole, Aspirin and Rofecoxib on Prostaglandin (PGE2) Production, Cyclooxygenase-2 Enzyme Activity and PCNA Expression in Patients With Barrett's Esophagus
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
June 2003 (Actual)
Study Completion Date
June 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
This study evaluates PGE2 production, COX-2 enzyme activity and PCNA expression in Barrett's metaplastic tissue. All patients will have a baseline endoscopy with multiple biopsies. The patients will then be receive four dosing regimens (esomeprazole, esomeprazole and aspirin, esomeprazole and rofecoxib, or rofecoxib alone) consecutively each for a 10 day dosing period, whilst undergoing further follow up endoscopies and multiple biopsies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett's Esophagus
Keywords
Barrett's Esophagus, Nexium
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Nexium 40mg
Arm Title
2
Arm Type
Experimental
Arm Description
Nexium 40mg + aspirin
Arm Title
3
Arm Type
Experimental
Arm Description
Nexium 40mg + Rofecoxib 25 mg
Arm Title
4
Arm Type
Active Comparator
Arm Description
Rofecoxib 25mg
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Other Intervention Name(s)
Nexium
Intervention Description
40mg twice daily
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Type
Drug
Intervention Name(s)
Rofecoxib
Intervention Description
25mg once daily
Primary Outcome Measure Information:
Title
Measure PGE production in Barrett's metastatic tissue & determine the reduction from baseline of PGE production would be equivalent on Day 10 in esomeprazole 40mg bid + aspirin treatment compared to esomeprazole 40 mg bid + rofecoxib 25 mg qd treatment
Time Frame
Baseline esophageal biopsies will be taken and thereafter at Day 10 in each treatment period.
Secondary Outcome Measure Information:
Title
To determine in which of the four treatment groups the reduction in the baseline in PGE2 production, COX-2 enzyme activity and PCNA expression in Barrett's metaplastic tissue is the greatest.
Time Frame
Baseline esophageal biopsies will be taken and thereafter at Day 10 in each treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A biopsy-proven diagnosis of Barrett's esophagus segment length greater than 2cm with no dysplasia or adenocarcinoma.
Clinically normal laboratory results and physical findings at screening.
Exclusion Criteria:
A history of esophageal, gastric or duodenal surgery, including antireflux surgery or endoscopic antireflux procedures, except for simple closure of an ulcer.
Evidence of the following diseases or conditions:
Barrett's esophagus less than or greater than 2cm that is positive for high grade dysplasia or adenocarcinoma
Signs and symptoms of gastric outlet obstruction
Active peptic ulcer disease
severe liver disease
Pancreatitis
Malabsorption
Active inflammatory bowel disease
Severe pulmonary, cardiovascular or renal disease
Impaired renal function or abnormal urine sediment on repeated examinations
esophageal stricture or active, severe esophagitis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula Fernstrom
Organizational Affiliation
Nexium Global Product Director, AstraZeneca
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Barrett's Esophagus - 315 - 3 Way Cross Over
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