Barrett's Esophagus - 315 - 3 Way Cross Over - Tabular View

Tracking Information

First Received Date ^ICMJE

March 11, 2008

Last Updated Date

March 25, 2009

Start Date ^ICMJE

April 2002

Primary Completion Date

June 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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. ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00637988 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Barrett's Esophagus - 315 - 3 Way Cross Over

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Crossover Assignment, Efficacy Study

Condition ^ICMJE

Barrett's Esophagus

Intervention ^ICMJE

Drug: Esomeprazole
Drug: Aspirin
Drug: Rofecoxib

Study Arms / Comparison Groups

Experimental: Nexium 40mg
Experimental: Nexium 40mg + aspirin
Experimental: Nexium 40mg + Rofecoxib 25 mg
Active Comparator: Rofecoxib 25mg

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

June 2003

Primary Completion Date

June 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00637988

Responsible Party

Tore Lind, MD - Nexium Medical Science Director, Astra Zeneca

Study ID Numbers ^ICMJE

316, D9612L00057

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Paula Fernstrom

Nexium Global Product Director, AstraZeneca

Information Provided By

AstraZeneca

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP