Back to resultsEsomeprazole for Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs
Primary Purpose
NSAIDs, Upper GI Symptoms
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Esomeprazole
Sponsored by
About this trial
This is an interventional treatment trial for NSAIDs
Eligibility Criteria
Inclusion Criteria: Signed informed consent. Completed the SH-NEN-0003 study with relief of upper GI symptom. Relief is defined as "last 7 days with a diary assessment of None or Minimal, but allowing up to 2 days to be rated as Mild during the 7-day period". A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid arthritis) that requires continuous daily NSAID treatment for at least 6 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 NSAIDs. Daily NSAID treatment dose and type: Must have been stable for at least 9 weeks prior to inclusion Are expected to remain stable for the duration of the study. Must be administered orally. If more than one type of NSAID treatment is used, at least one type must be administered orally. Hp negative on Histology performed at baseline endoscopy in the study SHNEN-0003. Exclusion Criteria: Discontinuation from study SH-NEN-0003 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. Pregnancy or lactation. Women of childbearing potential must maintain effective contraception during the study period as judged by the investigator.
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Outcomes
Primary Outcome Measures
To assess the efficacy of esomeprazole versus placebo through 6 months of treatment for the prevention of relapse of upper GI symptom associated with NSAID use
Secondary Outcome Measures
To assess the safety & tolerability of esomeprazole versus placebo when administered for 6 months to patients receiving daily NSAID therapy.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00241553
Brief Title
Esomeprazole for Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs
Official Title
Efficacy of Esomeprazole 40 mg Once Daily Versus Placebo or Esomeprazole 20 mg Once Daily Versus Placebo in Prevention 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
April 2001 (undefined)
Primary Completion Date
February 2003 (Actual)
Study Completion Date
February 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
This study was a multicentre, double-blind, randomised, placebo-controlled parallel group study consisting of 4 visits over a period of 6 months. The primary variable was to assess theefficacy of esomeprazole 40 mg orally qd (E40) or esomeprazole 20 mg orally qd (E20) versus placebo orally qd after 6 months of treatment for the prevention of relapse of upper GI symptoms associated with NSAID use, including COX-2 selective NSAIDs, in patients receiving daily NSAID therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NSAIDs, Upper GI Symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
276 (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 6 months of treatment for the prevention of relapse of upper GI symptom associated with NSAID use
Secondary Outcome Measure Information:
Title
To assess the safety & tolerability of esomeprazole versus placebo when administered for 6 months to patients receiving daily NSAID therapy.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent.
Completed the SH-NEN-0003 study with relief of upper GI symptom. Relief is defined as "last 7 days with a diary assessment of None or Minimal, but allowing up to 2 days to be rated as Mild during the 7-day period".
A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid arthritis) that requires continuous daily NSAID treatment for at least 6 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 NSAIDs.
Daily NSAID treatment dose and type:
Must have been stable for at least 9 weeks prior to inclusion
Are expected to remain stable for the duration of the study.
Must be administered orally. If more than one type of NSAID treatment is used, at least one type must be administered orally.
Hp negative on Histology performed at baseline endoscopy in the study SHNEN-0003.
Exclusion Criteria:
Discontinuation from study SH-NEN-0003
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.
Pregnancy or lactation. Women of childbearing potential must maintain effective contraception during the study period as judged by the investigator.
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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Tallassee
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Phoenix
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Spennymoor
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Woking
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Trowbridge
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Ashford
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Audley
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Bath
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Bradford upon Avon
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Chesterfield
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Coventry
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Crawley
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Ely
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Folkestone
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Glasgow
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Kilmarnock
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Leigh
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Nottingham
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Watford
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Wigston
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Woking
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United Kingdom
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Worsley
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United Kingdom
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Yoxall
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United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
17391505
Citation
Hawkey CJ, Talley NJ, Scheiman JM, Jones RH, Langstrom G, Naesdal J, Yeomans ND; NASA/SPACE author group. Maintenance treatment with esomeprazole following initial relief of non-steroidal anti-inflammatory drug-associated upper gastrointestinal symptoms: the NASA2 and SPACE2 studies. Arthritis Res Ther. 2007;9(1):R17. doi: 10.1186/ar2124.
Results Reference
derived
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Esomeprazole for Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs
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