Back to resultsEsomeprazole for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs
Primary Purpose
GERD
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Esomeprazole
Sponsored by
About this trial
This is an interventional treatment trial for GERD focused on measuring NSAIDs, Upper GI symptoms
Eligibility Criteria
Inclusion Criteria: 18 years of age, or older. Capable of completing the diary card. Ability to complete the HRQL questionnaires. A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid arthritis) that requires continuous daily NSAID treatment for at least 7 months. Daily NSAID treatment is defined as taking the prescribed dose for at least 5 of 7 days in any given week and can include COX-2 selective NSAIDs, multiple NSAIDs, and high-dose aspirin (>325 mg/day). Daily NSAID treatment dose and type: (Must have been stable for at least 4 weeks prior to baseline endoscopy and; Are expected to remain stable for the duration of the study. and; Must be administered orally for the duration of the study. If more than one type of NSAID treatment is used, at least one type must be given orally). Exclusion Criteria: Current, or history of, gastric or duodenal ulcer Current, or history of, esophageal, gastric or duodenal surgery. History of GERD, not associated with NSAID use. Pain, discomfort or burning in the upper abdomen precipitated by exercise or relieved by defecation. Pain, discomfort or burning in the upper abdomen not associated with the use of NSAIDs, including COX-2 selective NSAIDs, as judged by the investigator. Endoscopic Barrett's esophagus(>3 cm) or significant dysplastic changes in the esophagus
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Outcomes
Primary Outcome Measures
To assess the efficacy of esomeprazole versus placebo through 4 weeks of treatment of upper GI symptoms associated with nonsteroidal anti-inflammation
Secondary Outcome Measures
- To assess the safety & tolerability of esomeprazole versus placebo when administered for up to 4 weeks to patients receiving daily NSAID therapy
- To assess the impact of treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00241540
Brief Title
Esomeprazole for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs
Official Title
Efficacy of Esomeprazole 40 mg Once Daily Versus Placebo & Esomeprazole 20 mg Once Daily Versus Placebo in Treatment for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs Including COX-2 Selective NSAIDs
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
August 2002 (Actual)
Study Completion Date
August 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
This study is a randomised, double-blind, parallel-group and placebo controlled study comparing the efficacy of esomeprazole 40 mg orally qd vs. placebo and esomeprazole 20 mg orally qd vs. placebo when given to patients on continuous use of NSAIDs, including COX-2 selective NSAIDs, for a period of 4 weeks in treatment of relief of upper GI symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GERD
Keywords
NSAIDs, Upper GI symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
808 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Primary Outcome Measure Information:
Title
To assess the efficacy of esomeprazole versus placebo through 4 weeks of treatment of upper GI symptoms associated with nonsteroidal anti-inflammation
Secondary Outcome Measure Information:
Title
- To assess the safety & tolerability of esomeprazole versus placebo when administered for up to 4 weeks to patients receiving daily NSAID therapy
Title
- To assess the impact of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age, or older.
Capable of completing the diary card.
Ability to complete the HRQL questionnaires.
A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid arthritis) that requires continuous daily NSAID treatment for at least 7 months.
Daily NSAID treatment is defined as taking the prescribed dose for at least 5 of 7 days in any given week and can include COX-2 selective NSAIDs, multiple NSAIDs, and high-dose aspirin (>325 mg/day).
Daily NSAID treatment dose and type: (Must have been stable for at least 4 weeks prior to baseline endoscopy and; Are expected to remain stable for the duration of the study. and; Must be administered orally for the duration of the study. If more than one type of NSAID treatment is used, at least one type must be given orally).
Exclusion Criteria:
Current, or history of, gastric or duodenal ulcer
Current, or history of, esophageal, gastric or duodenal surgery.
History of GERD, not associated with NSAID use.
Pain, discomfort or burning in the upper abdomen precipitated by exercise or relieved by defecation.
Pain, discomfort or burning in the upper abdomen not associated with the use of NSAIDs, including COX-2 selective NSAIDs, as judged by the investigator.
Endoscopic Barrett's esophagus(>3 cm) or significant dysplastic changes in the esophagus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Nexium Medical Sciences Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
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Tucson
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Arizona
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United States
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Anaheim
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California
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United States
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Orange
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California
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United States
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San Francisco
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California
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United States
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Bradenton
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Florida
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United States
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Clearwater
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Florida
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United States
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Ft. Lauderdale
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Florida
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United States
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Jacksonville
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Florida
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United States
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South Miami
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Florida
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United States
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West Palm Beach
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Florida
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United States
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Zephyr Hills
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Florida
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United States
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Conyers
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Georgia
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United States
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Newburgh
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Indiana
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United States
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Baltimore
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United States
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Winston-Salem
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United States
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Tulsa
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Oklahoma
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United States
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Tipton
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United States
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Norfolk
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United States
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Virginia Beach
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Virginia
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United States
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Alleur
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Belgium
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Ans
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Belgium
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Beernem
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Belgium
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Betekom
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Belgium
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Bottelaere
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Belgium
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Braine-L 'Alleud
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Belgium
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Brussels (Ixelles)
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Belgium
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Brussels (Jette)
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Belgium
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Brussels (Uccle)
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Belgium
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Buizingen
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Belgium
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Duffel
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Belgium
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Durnal
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Belgium
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Erembodegem
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Belgium
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Forest
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Belgium
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Genk
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Belgium
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Gent
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Belgium
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Halle
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Belgium
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Herentals
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Belgium
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Lambermont
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Belgium
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Leut
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Belgium
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Linkebeek
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Belgium
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Liège
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Belgium
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Maasmechelen
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Belgium
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Massemen
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Belgium
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Merelbeke
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Natoye
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Belgium
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Nivelles
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Belgium
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Belgium
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Seraing
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Belgium
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Soignies
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Belgium
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Uccle
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Belgium
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Vorst (Brussels)
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Belgium
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Waremme
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Belgium
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Zoersel
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Belgium
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Zolder
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Albens
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France
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Angers
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France
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France
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France
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France
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France
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La Regrip
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France
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France
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Lille
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France
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Lyon
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France
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Maromme
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France
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France
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Montingy Les Metz
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France
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Paris
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France
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France
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Strasbourg
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France
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Tarare
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France
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Berlin
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Germany
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Bernau
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Dresden
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Germany
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Erfurt
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Erlangen
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Genthin
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Germany
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Herne
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Germany
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Kelkheim
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Germany
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Köln
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Germany
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Künzing
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Germany
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Lienen
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Germany
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Lüdenscheid
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Münster
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Salzgitter
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Stockach
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Wangen
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Wiesbaden
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Germany
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Wolmirstedt
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Germany
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Budapest
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Hungary
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Békéscsaba
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Hungary
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Dunaújváros
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Hungary
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Szentes
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Hungary
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Szombathely
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Hungary
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Veszprém
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Hungary
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Vác
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Hungary
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Barcelona
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Spain
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Getafe
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Spain
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Guadalajara
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Spain
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Madrid
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Spain
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Mérida
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Spain
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Palma de Mallorca
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Spain
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San Sebastián(Guipuzcoa)
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Spain
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Sevilla
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Spain
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Torrelavega
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Spain
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Valencia
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Spain
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Viladecans
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Spain
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Zaragoza
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Esomeprazole for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs
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