Status:
COMPLETED
Barrett's Esophagus - 315 - 3 Way Cross Over
Lead Sponsor:
AstraZeneca
Conditions:
Barrett's Esophagus
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2003
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00637988
Start Date
April 1 2002
End Date
June 1 2003
Last Update
January 21 2011
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