Back to resultsEsomeprazole for Prevention 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: Signed informed consent. Completed the SH-NEN-0001 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 and; Are expected to remain stable for the duration of the study. and; 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- 0001. Exclusion Criteria: Discontinuation from study SH-NEN-0001 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. Need for continuous concomitant therapy with: (Anticoagulants; Corticosteroids at doses higher than explained under inclusion criterion)
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Outcomes
Primary Outcome Measures
To assess the efficacy of esomeprazole 40 mg orally q.d. versus placebo orally q.d.
and 20 mg q.d. versus placebo orally q.d. through 6 months of treatment for the
prevention of relapse of upper GI symptom associated with NSAID use in patients
receiving daily NSAID therapy.
Secondary Outcome Measures
To assess the safety and tolerability of esomeprazole 40 mg orally q.d. versus placebo orally q.d. and 20 mg orally q.d. versus placebo orally q.d. when administered for 6 months to patients receiving daily NSAID therapy.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00241514
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
February 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 the efficacy 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
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
334 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Primary Outcome Measure Information:
Title
To assess the efficacy of esomeprazole 40 mg orally q.d. versus placebo orally q.d.
Title
and 20 mg q.d. versus placebo orally q.d. through 6 months of treatment for the
Title
prevention of relapse of upper GI symptom associated with NSAID use in patients
Title
receiving daily NSAID therapy.
Secondary Outcome Measure Information:
Title
To assess the safety and tolerability of esomeprazole 40 mg orally q.d. versus placebo orally q.d. and 20 mg orally q.d. versus placebo orally q.d. 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-0001 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 and; Are expected to remain stable for the duration of the study. and; 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- 0001.
Exclusion Criteria:
Discontinuation from study SH-NEN-0001
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.
Need for continuous concomitant therapy with: (Anticoagulants; Corticosteroids at doses higher than explained under inclusion criterion)
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:
Facility Name
Research Site
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Anaheim
State/Province
California
Country
United States
Facility Name
Research Site
City
Orange
State/Province
California
Country
United States
Facility Name
Research Site
City
San Francisco
State/Province
California
Country
United States
Facility Name
Research Site
City
Bradenton
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Ft. Lauderdale
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Research Site
City
South Miami
State/Province
Florida
Country
United States
Facility Name
Research Site
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Zephyr Hills
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Conyers
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Newburgh
State/Province
Indiana
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
Research Site
City
Tipton
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Virginia Beach
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Alleur
Country
Belgium
Facility Name
Research Site
City
Ans
Country
Belgium
Facility Name
Research Site
City
Beernem
Country
Belgium
Facility Name
Research Site
City
Betekom
Country
Belgium
Facility Name
Research Site
City
Bottelaere
Country
Belgium
Facility Name
Research Site
City
Braine-L 'Alleud
Country
Belgium
Facility Name
Research Site
City
Buizingen
Country
Belgium
Facility Name
Research Site
City
Duffel
Country
Belgium
Facility Name
Research Site
City
Durnal
Country
Belgium
Facility Name
Research Site
City
Erembodegem
Country
Belgium
Facility Name
Research Site
City
Genk
Country
Belgium
Facility Name
Research Site
City
Gent
Country
Belgium
Facility Name
Research Site
City
Herentals
Country
Belgium
Facility Name
Research Site
City
Lambermont
Country
Belgium
Facility Name
Research Site
City
Leut
Country
Belgium
Facility Name
Research Site
City
Linkebeek
Country
Belgium
Facility Name
Research Site
City
Liège
Country
Belgium
Facility Name
Research Site
City
Maasmechelen
Country
Belgium
Facility Name
Research Site
City
Massemen
Country
Belgium
Facility Name
Research Site
City
Merelbeke
Country
Belgium
Facility Name
Research Site
City
Natoye
Country
Belgium
Facility Name
Research Site
City
Nivelles
Country
Belgium
Facility Name
Research Site
City
Oud-Heverlee
Country
Belgium
Facility Name
Research Site
City
Seraing
Country
Belgium
Facility Name
Research Site
City
Soignies
Country
Belgium
Facility Name
Research Site
City
Vorst (Brussels)
Country
Belgium
Facility Name
Research Site
City
Waremme
Country
Belgium
Facility Name
Research Site
City
Zoersel
Country
Belgium
Facility Name
Research Site
City
Zolder
Country
Belgium
Facility Name
Research Site
City
Albens
Country
France
Facility Name
Research Site
City
Angers
Country
France
Facility Name
Research Site
City
Dambach La Ville
Country
France
Facility Name
Research Site
City
Dommartin-les-touls
Country
France
Facility Name
Research Site
City
Fontaine Les Dijon
Country
France
Facility Name
Research Site
City
Gemenos
Country
France
Facility Name
Research Site
City
Geste
Country
France
Facility Name
Research Site
City
Husseren-wesserling
Country
France
Facility Name
Research Site
City
La Regrip
Country
France
Facility Name
Research Site
City
Le Pian Medoc
Country
France
Facility Name
Research Site
City
Lille
Country
France
Facility Name
Research Site
City
Lyon
Country
France
Facility Name
Research Site
City
Maromme
Country
France
Facility Name
Research Site
City
MONT DE MARSAN Cedex
Country
France
Facility Name
Research Site
City
Montingy Les Metz
Country
France
Facility Name
Research Site
City
Paris Cedex 10
Country
France
Facility Name
Research Site
City
Saint-ouen
Country
France
Facility Name
Research Site
City
Strasbourg
Country
France
Facility Name
Research Site
City
Tarare
Country
France
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Bernau
Country
Germany
Facility Name
Research Site
City
Bochum
Country
Germany
Facility Name
Research Site
City
Dresden-Test
Country
Germany
Facility Name
Research Site
City
Dresden
Country
Germany
Facility Name
Research Site
City
Erfurt
Country
Germany
Facility Name
Research Site
City
Erlangen
Country
Germany
Facility Name
Research Site
City
Genthin
Country
Germany
Facility Name
Research Site
City
Herne
Country
Germany
Facility Name
Research Site
City
Kelkheim
Country
Germany
Facility Name
Research Site
City
Köln
Country
Germany
Facility Name
Research Site
City
Künzing
Country
Germany
Facility Name
Research Site
City
Lienen
Country
Germany
Facility Name
Research Site
City
Lüdenscheid
Country
Germany
Facility Name
Research Site
City
München
Country
Germany
Facility Name
Research Site
City
Münster
Country
Germany
Facility Name
Research Site
City
Paderborn
Country
Germany
Facility Name
Research Site
City
Passau
Country
Germany
Facility Name
Research Site
City
Potsdam
Country
Germany
Facility Name
Research Site
City
Ratingen
Country
Germany
Facility Name
Research Site
City
Regensburg
Country
Germany
Facility Name
Research Site
City
Ribnitz-Damgarten
Country
Germany
Facility Name
Research Site
City
Saarbrücken
Country
Germany
Facility Name
Research Site
City
Salzgitter
Country
Germany
Facility Name
Research Site
City
Wangen
Country
Germany
Facility Name
Research Site
City
Wiesbaden
Country
Germany
Facility Name
Research Site
City
Wolmirstedt
Country
Germany
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Békéscsaba
Country
Hungary
Facility Name
Research Site
City
Dunaújváros
Country
Hungary
Facility Name
Research Site
City
Szentes
Country
Hungary
Facility Name
Research Site
City
Szombathely
Country
Hungary
Facility Name
Research Site
City
Veszprém
Country
Hungary
Facility Name
Research Site
City
Vác
Country
Hungary
Facility Name
Research Site
City
Barcelona
Country
Spain
Facility Name
Research Site
City
Getafe
Country
Spain
Facility Name
Research Site
City
Guadalajara
Country
Spain
Facility Name
Research Site
City
Madrid
Country
Spain
Facility Name
Research Site
City
Mérida
Country
Spain
Facility Name
Research Site
City
Palma de Mallorca
Country
Spain
Facility Name
Research Site
City
San Sebastián(Guipuzcoa)
Country
Spain
Facility Name
Research Site
City
Sevilla
Country
Spain
Facility Name
Research Site
City
Torrelavega
Country
Spain
Facility Name
Research Site
City
Valencia
Country
Spain
Facility Name
Research Site
City
Viladecans
Country
Spain
Facility Name
Research Site
City
Zaragoza
Country
Spain
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
Learn more about this trial
Esomeprazole for Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs
We'll reach out to this number within 24 hrs