Clinical trial · Interventional
Barrett's Esophagus - 315 - 3 Way Cross Over
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett's Esophagus | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aspirin | Drug | Aspirin | ALIAS |
| Esomeprazole | Drug | — | UNRESOLVED |
| Rofecoxib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- 1
- description
- Nexium 40mg
- interventionNames
- Drug: Esomeprazole
- type
- EXPERIMENTAL
- label
- 2
- description
- Nexium 40mg + aspirin
- interventionNames
- Drug: Esomeprazole
- Drug: Aspirin
- type
- EXPERIMENTAL
- label
- 3
- description
- Nexium 40mg + Rofecoxib 25 mg
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available