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

NCT ID: NCT00241527

Last Updated: 2011-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

556 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-12-31

Study Completion Date

2002-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study was 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 treatment period of 4 weeks for relief of upper GI symptoms.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

NSAIDs Upper GI Symptoms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Esomeprazole

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Signed informed consent.
* 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.)
* Hp negative by UBT, serology or biopsy based test, at visit 1.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

AstraZeneca Nexium Medical Sciences Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Tallassee, Alabama, United States

Site Status

Research Site

Phoenix, Arizona, United States

Site Status

Research Site

Garden Grove, California, United States

Site Status

Research Site

Orange, California, United States

Site Status

Research Site

Bradenton, Florida, United States

Site Status

Research Site

Coral Gables, Florida, United States

Site Status

Research Site

Hollywood, Florida, United States

Site Status

Research Site

St. Petersburg, Florida, United States

Site Status

Research Site

Tavares, Florida, United States

Site Status

Research Site

Zephyrhills, Florida, United States

Site Status

Research Site

Nampa, Idaho, United States

Site Status

Research Site

Elkhart, Indiana, United States

Site Status

Research Site

Evansville, Indiana, United States

Site Status

Research Site

Newburgh, Indiana, United States

Site Status

Research Site

Wichita, Kansas, United States

Site Status

Research Site

Hollywood, Maryland, United States

Site Status

Research Site

Butte, Montana, United States

Site Status

Research Site

Princeton, New Jersey, United States

Site Status

Research Site

Toms River, New Jersey, United States

Site Status

Research Site

Endwell, New York, United States

Site Status

Research Site

Hewlett, New York, United States

Site Status

Research Site

Charlotte, North Carolina, United States

Site Status

Research Site

Winston-Salem, North Carolina, United States

Site Status

Research Site

Duncansville, Pennsylvania, United States

Site Status

Research Site

Erie, Pennsylvania, United States

Site Status

Research Site

Jackson, Tennessee, United States

Site Status

Research Site

Pasadena, Texas, United States

Site Status

Research Site

Waco, Texas, United States

Site Status

Research Site

Edmonds, Washington, United States

Site Status

Research Site

Olympia, Washington, United States

Site Status

Research Site

Greenfield, Wisconsin, United States

Site Status

Research Site

Milwaukee, Wisconsin, United States

Site Status

Research Site

Five Dock, New South Wales, Australia

Site Status

Research Site

Carina Heights, Queensland, Australia

Site Status

Research Site

Kippa-Ring, Queensland, Australia

Site Status

Research Site

Ivanhoe, Victoria, Australia

Site Status

Research Site

Edmonton, Alberta, Canada

Site Status

Research Site

Winnipeg, Manitoba, Canada

Site Status

Research Site

Mount Pearl, Newfoundland and Labrador, Canada

Site Status

Research Site

St. John's, Newfoundland and Labrador, Canada

Site Status

Research Site

Hamilton, Ontario, Canada

Site Status

Research Site

Kitchener, Ontario, Canada

Site Status

Research Site

Newmarket, Ontario, Canada

Site Status

Research Site

Ottawa, Ontario, Canada

Site Status

Research Site

Toronto, Ontario, Canada

Site Status

Research Site

Windsor, Ontario, Canada

Site Status

Research Site

Montreal, Quebec, Canada

Site Status

Research Site

Québec, Quebec, Canada

Site Status

Research Site

Sainte-Foy, Quebec, Canada

Site Status

Research Site

Sherbrooke, Quebec, Canada

Site Status

Research Site

Saskatoon, Saskatchewan, Canada

Site Status

Research Site

Quesnel, , Canada

Site Status

Research Site

St. John's, , Canada

Site Status

Research Site

Ostrava, , Czechia

Site Status

Research Site

Prague, , Czechia

Site Status

Research Site

Bari, BA, Italy

Site Status

Research Site

Genova, GE, Italy

Site Status

Research Site

Milan, MI, Italy

Site Status

Research Site

Perugia, PG, Italy

Site Status

Research Site

Vicenza, VI, Italy

Site Status

Research Site

Napoli, , Italy

Site Status

Research Site

Verona, , Italy

Site Status

Research Site

Bergen, , Norway

Site Status

Research Site

Bodø, , Norway

Site Status

Research Site

Bærum Postterminal, , Norway

Site Status

Research Site

Gjøvik, , Norway

Site Status

Research Site

Horten, , Norway

Site Status

Research Site

Kristiansand, , Norway

Site Status

Research Site

Lillehammer, , Norway

Site Status

Research Site

Nesttun, , Norway

Site Status

Research Site

Oslo, , Norway

Site Status

Research Site

Sandvika, , Norway

Site Status

Research Site

Skien, , Norway

Site Status

Research Site

Stavanger, , Norway

Site Status

Research Site

Tromsø, , Norway

Site Status

Research Site

Bydgoszcz, , Poland

Site Status

Research Site

Sopot, , Poland

Site Status

Research Site

Warsaw, , Poland

Site Status

Research Site

Bratislava, , Slovakia

Site Status

Research Site

Nové Mesto nad Váhom, , Slovakia

Site Status

Research Site

Bloemfontein, , South Africa

Site Status

Research Site

Cape Town, , South Africa

Site Status

Research Site

Johannesburg, , South Africa

Site Status

Research Site

Pretoria, , South Africa

Site Status

Research Site

Bredbyn, , Sweden

Site Status

Sweden

Gävle, , Sweden

Site Status

Research Site

Karlskrona, , Sweden

Site Status

Research Site

Kungälv, , Sweden

Site Status

Research Site

Lidköping, , Sweden

Site Status

Research Site

Malmo, , Sweden

Site Status

Research Site

Oskarshamn, , Sweden

Site Status

Research Site

Örnsköldsvik, , Sweden

Site Status

Research Site

Östersund, , Sweden

Site Status

Research Site

Rättvik, , Sweden

Site Status

Research Site

Skövde, , Sweden

Site Status

Research Site

Stockholm, , Sweden

Site Status

Research Site

Trehörningsjö, , Sweden

Site Status

Research Site

Trollhättan, , Sweden

Site Status

Research Site

Varberg, , Sweden

Site Status

Research Site

Värnamo, , Sweden

Site Status

Research Site

Västervik, , Sweden

Site Status

Research Site

Reading, Berks, United Kingdom

Site Status

Research Site

Spennymoor, Co. Durham, United Kingdom

Site Status

Research Site

Woking, Surrey, United Kingdom

Site Status

Research Site

Trowbridge, Wiltshire, United Kingdom

Site Status

Research Site

Ashford, , United Kingdom

Site Status

Research Site

Audley, , United Kingdom

Site Status

Research Site

Bath, , United Kingdom

Site Status

Research Site

Bradford Upon Avon, , United Kingdom

Site Status

Research Site

Chesterfield, , United Kingdom

Site Status

Research Site

Coventry, , United Kingdom

Site Status

Research Site

Crawley, , United Kingdom

Site Status

Research Site

Ely, , United Kingdom

Site Status

Research Site

Folkestone, , United Kingdom

Site Status

Research Site

Glasgow, , United Kingdom

Site Status

Research Site

Kilmarnock, , United Kingdom

Site Status

Research Site

Leigh, , United Kingdom

Site Status

Research Site

Mansfield, , United Kingdom

Site Status

Research Site

Nottingham, , United Kingdom

Site Status

Research Site

Pontefract, , United Kingdom

Site Status

Research Site

Royal Tunbridge Wells, , United Kingdom

Site Status

Research Site

Shrewsbury, , United Kingdom

Site Status

Research Site

Stafford, , United Kingdom

Site Status

Research Site

Swansea, , United Kingdom

Site Status

Research Site

Trowbridge, , United Kingdom

Site Status

Research Site

Watford, , United Kingdom

Site Status

Research Site

Wigston, , United Kingdom

Site Status

Research Site

Woking, , United Kingdom

Site Status

Research Site

Worsley, , United Kingdom

Site Status

Research Site

Yoxall, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Australia Canada Czechia Italy Norway Poland Slovakia South Africa Sweden United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SH-NEN-0003

Identifier Type: -

Identifier Source: secondary_id

D9617C00003

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Prevention of Gastric Ulcers
NCT00629512 COMPLETED PHASE3
Ulcer Prevention II
NCT00629928 COMPLETED PHASE3
Nexium Dyspepsia/AST
NCT00251914 COMPLETED PHASE3