Esomeprazole for Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs

January 21, 2011 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: Esomeprazole

Study Type

Interventional

Enrollment

276

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- New South Wales
  - Five Dock, New South Wales, Australia
    - Research Site
  - Various Cities, New South Wales, Australia
    - Research Site
- Queensland
  - Carina Heights, Queensland, Australia
    - Research Site
  - Kippa Ring, Queensland, Australia
    - Research Site
- South Australia
  - Various Cities, South Australia, Australia
    - Research Site
- Tasmania
  - Various Cities, Tasmania, Australia
    - Research Site
- Victoria
  - Ivanhoe, Victoria, Australia
    - Research Site
  - Various Cities, Victoria, Australia
    - Research Site
Canada
- - Quebec, Canada
    - Research Site
- Alberta
  - Edmonton, Alberta, Canada
    - Research Site
- British Columbia
  - Quesnel, British Columbia, Canada
    - Research Site
- Manitoba
  - Winnipeg, Manitoba, Canada
    - Research Site
- Newfoundland and Labrador
  - Mount Pearl, Newfoundland and Labrador, Canada
    - Research Site
  - St. John's, Newfoundland and Labrador, Canada
    - Research Site
- Ontario
  - Hamilton, Ontario, Canada
    - Research Site
  - Kitchener, Ontario, Canada
    - Research Site
  - Newmarket, Ontario, Canada
    - Research Site
  - Ottawa, Ontario, Canada
    - Research Site
  - Toronto, Ontario, Canada
    - Research Site
  - Windsor, Ontario, Canada
    - Research Site
- Quebec
  - Montreal, Quebec, Canada
    - Research Site
  - Sainte-Foy, Quebec, Canada
    - Research Site
  - Sherbrooke, Quebec, Canada
    - Research Site
- Saskatchewan
  - Saskatoon, Saskatchewan, Canada
    - Research Site
Czech Republic
- - Hlu¿ín, Czech Republic
    - Research Site
  - Ostrava, Czech Republic
    - Research Site
  - Ostrava - T¿ebovice, Czech Republic
    - Research Site
  - Praha 2, Czech Republic
    - Research Site
  - Praha 5, Czech Republic
    - Research Site
Italy
- - Napoli, Italy
    - Research Site
  - Parma, Italy
    - Research Site
  - Perugia, Italy
    - Research Site
  - Verona, Italy
    - Research Site
- BA
  - Bari, BA, Italy
    - Research Site
- GE
  - Genova, GE, Italy
    - Research Site
- MI
  - Milano, MI, Italy
    - Research Site
- VI
  - Vicenza, VI, Italy
    - Research Site
Norway
- - Bergen, Norway
    - Research Site
  - Bodø, Norway
    - Research Site
  - Bærum postterminal, Norway
    - Research Site
  - Gjøvik, Norway
    - Research Site
  - Horten, Norway
    - Research Site
  - Lillehammer, Norway
    - Research Site
  - Nesttun, Norway
    - Research Site
  - Oslo, Norway
    - Research Site
  - Sandvika, Norway
    - Research Site
  - Skien, Norway
    - Research Site
  - Stavanger, Norway
    - Research Site
  - Tromsø, Norway
    - Research Site
Poland
- - Bia¿ystok, Poland
    - Research Site
  - Bydgoszcz, Poland
    - Research Site
  - Sopot, Poland
    - Research Site
  - Warszawa, Poland
    - Research Site
  - Wrze¿nia, Poland
    - Research Site
Slovakia
- - Bratislava, Slovakia
    - Research Site
  - Nové Mesto nad Váhom, Slovakia
    - Research Site
  - Pie¿¿any, Slovakia
    - Research Site
South Africa
- - Bloemfontein, South Africa
    - Research Site
  - Cape Town, South Africa
    - Research Site
  - Johannesburg, South Africa
    - Research Site
Sweden
- - Bredbyn, Sweden
    - Research Site
  - Gävle, Sweden
    - Research Site
  - Karlskrona, Sweden
    - Research Site
  - Kungälv, Sweden
    - Research Site
  - Lidköping, Sweden
    - Research Site
  - Malmö, Sweden
    - Research Site
  - Oskarshamn, Sweden
    - Research Site
  - Rättvik, Sweden
    - Research Site
  - Skövde, Sweden
    - Research Site
  - Stockholm, Sweden
    - Research Site
  - Trehörningsjö, Sweden
    - Research Site
  - Trollhättan, Sweden
    - Research Site
  - Varberg, Sweden
    - Research Site
  - Värnamo, Sweden
    - Research Site
  - Västervik, Sweden
    - Research Site
  - Örnsköldsvik, Sweden
    - Research Site
  - Östersund, Sweden
    - Research Site
United Kingdom
- - Ashford, United Kingdom
    - Research Site
  - Audley, United Kingdom
    - Research Site
  - Bath, United Kingdom
    - Research Site
  - Bradford upon Avon, United Kingdom
    - Research Site
  - Chesterfield, United Kingdom
    - Research Site
  - Coventry, United Kingdom
    - Research Site
  - Crawley, United Kingdom
    - Research Site
  - Ely, United Kingdom
    - Research Site
  - Folkestone, United Kingdom
    - Research Site
  - Glasgow, United Kingdom
    - Research Site
  - Kilmarnock, United Kingdom
    - Research Site
  - Leigh, United Kingdom
    - Research Site
  - Mansfield, United Kingdom
    - Research Site
  - Nottingham, United Kingdom
    - Research Site
  - Pontefract, United Kingdom
    - Research Site
  - Shrewsbury, United Kingdom
    - Research Site
  - Stafford, United Kingdom
    - Research Site
  - Swansea, United Kingdom
    - Research Site
  - Trowbridge, United Kingdom
    - Research Site
  - Tunbridge Wells, United Kingdom
    - Research Site
  - Watford, United Kingdom
    - Research Site
  - Wigston, United Kingdom
    - Research Site
  - Woking, United Kingdom
    - Research Site
  - Worsley, United Kingdom
    - Research Site
  - Yoxall, United Kingdom
    - Research Site
- Berks
  - Reading, Berks, United Kingdom
    - Research Site
- Co. Durham
  - Spennymoor, Co. Durham, United Kingdom
    - Research Site
- Surrey
  - Woking, Surrey, United Kingdom
    - Research Site
- Wiltshire
  - Trowbridge, Wiltshire, United Kingdom
    - Research Site
United States
- Alabama
  - Tallassee, Alabama, United States
    - Research Site
- Arizona
  - Phoenix, Arizona, United States
    - Research Site
- California
  - Garden Grove, California, United States
    - Research Site
  - Orange, California, United States
    - Research Site
- Florida
  - Bradenton, Florida, United States
    - Research Site
  - Coral Gables, Florida, United States
    - Research Site
  - Hollywood, Florida, United States
    - Research Site
  - St Petersburg, Florida, United States
    - Research Site
  - Tavares, Florida, United States
    - Research Site
  - Zephyr Hills, Florida, United States
    - Research Site
- Idaho
  - Nampa, Idaho, United States
    - Research Site
- Indiana
  - Elkhart, Indiana, United States
    - Research Site
  - Evansville, Indiana, United States
    - Research Site
  - Newburgh, Indiana, United States
    - Research Site
- Kansas
  - Wichita, Kansas, United States
    - Research Site
- Maryland
  - Hollywood, Maryland, United States
    - Research Site
- Montana
  - Butte, Montana, United States
    - Research Site
- New Jersey
  - Princeton, New Jersey, United States
    - Research Site
  - Toms River, New Jersey, United States
    - Research Site
- New York
  - Endwell, New York, United States
    - Research Site
  - Hewlett, New York, United States
    - Research Site
- North Carolina
  - Charlotte, North Carolina, United States
    - Research Site
  - Winston-Salem, North Carolina, United States
    - Research Site
- Pennsylvania
  - Duncansville, Pennsylvania, United States
    - Research Site
  - Erie, Pennsylvania, United States
    - Research Site
- Tennessee
  - Jackson, Tennessee, United States
    - Research Site
- Texas
  - Waco, Texas, United States
    - Research Site
- Washington
  - Edmonds, Washington, United States
    - Research Site
  - Olympia, Washington, United States
    - Research Site
- Wisconsin
  - Greenfield, Wisconsin, United States
    - Research Site
  - Milwaukee, Wisconsin, United States
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
To assess the safety & tolerability of esomeprazole versus placebo when administered for 6 months to patients receiving daily NSAID therapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Primary Completion (Actual)

February 1, 2003

Study Completion (Actual)

February 1, 2003

Study Registration Dates

First Submitted

October 18, 2005

First Submitted That Met QC Criteria

October 18, 2005

First Posted (Estimate)

October 19, 2005

Study Record Updates

Last Update Posted (Estimate)

January 24, 2011

Last Update Submitted That Met QC Criteria

January 21, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

D9617C00004
SH-NEN-0004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.