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 Magnesium
Sponsored by
About this trial
This is an interventional treatment trial for Barrett's Esophagus focused on measuring Nexium, Barrett's esophagus
Eligibility Criteria
Inclusion Criteria:
- Must have a previously established, biopsy-proven diagnosis of Barrett's esophagus with segment length greater than 3cm, with no dysplasia or adenocarcinoma within the previous 12 months
Exclusion Criteria:
- A history of esophageal, gastric, or duodenal surgery, including anti-reflux surgery or endoscopic anti-reflux procedures, except for simple closure of a gastric or duodenal ulcer.
- History of various gastrointestinal diseases - please see investigator for full list.
- Evidence of any malignant disease in the last 5 years, except minor superficial skin disease.
- Unstable diabetes mellitus. Stable on a controlled diet, oral agents or insulin are acceptable.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
1
2
3
Arm Description
40mg twice daily
40mg three times daily
20mg three times daily
Outcomes
Primary Outcome Measures
To compare the total percent time during the 24-hour monitoring period that gastric pH is above 4.0 at steady state in patients when taking: esomeprazole 40mg twice daily, esomeprazole 40mg three times daily, esomeprazole 20 mg three times daily.
Secondary Outcome Measures
Compare total percent time distal esophageal pH is above 4.0 at steady state for each treatment period.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00637559
Brief Title
Barrett's Esophagus - 315 - 3 Way Cross-Over
Official Title
A Multicenter, Double-blind, Three-way Crossover Intraesophageal and Intragastric pH Study of Three Esomeprazole Treatment Regimens in Documented Barrett's Esophagus Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
April 2003 (Actual)
Study Completion Date
April 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
This study looks the intragastric and intraesophageal pH in patients with documented Barrett's esophagus whilst taking esomeprazole 40mg twice daily, esomeprazole 40mg three times daily, esomeprazole 20 mg three times daily.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett's Esophagus
Keywords
Nexium, Barrett's esophagus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
40mg twice daily
Arm Title
2
Arm Type
Experimental
Arm Description
40mg three times daily
Arm Title
3
Arm Type
Experimental
Arm Description
20mg three times daily
Intervention Type
Drug
Intervention Name(s)
Esomeprazole Magnesium
Other Intervention Name(s)
Nexium
Primary Outcome Measure Information:
Title
To compare the total percent time during the 24-hour monitoring period that gastric pH is above 4.0 at steady state in patients when taking: esomeprazole 40mg twice daily, esomeprazole 40mg three times daily, esomeprazole 20 mg three times daily.
Time Frame
pH measured on Day 5
Secondary Outcome Measure Information:
Title
Compare total percent time distal esophageal pH is above 4.0 at steady state for each treatment period.
Time Frame
pH measured
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must have a previously established, biopsy-proven diagnosis of Barrett's esophagus with segment length greater than 3cm, with no dysplasia or adenocarcinoma within the previous 12 months
Exclusion Criteria:
A history of esophageal, gastric, or duodenal surgery, including anti-reflux surgery or endoscopic anti-reflux procedures, except for simple closure of a gastric or duodenal ulcer.
History of various gastrointestinal diseases - please see investigator for full list.
Evidence of any malignant disease in the last 5 years, except minor superficial skin disease.
Unstable diabetes mellitus. Stable on a controlled diet, oral agents or insulin are acceptable.
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
We'll reach out to this number within 24 hrs