Esomeprazole for Relief 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 and 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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: Esomeprazole

Study Type

Interventional

Enrollment

556

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
- Queensland
  - Carina Heights, Queensland, Australia
    - Research Site
  - Kippa Ring, Queensland, Australia
    - Research Site
- Victoria
  - Ivanhoe, Victoria, Australia
    - Research Site
Canada
- - Quebec, Canada
    - Research Site
  - Quesnel, Canada
    - Research Site
  - St. John's, Canada
    - Research Site
- Alberta
  - Edmonton, Alberta, 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
- - Ostrava, Czech Republic
    - Research Site
  - Praha 2, Czech Republic
    - Research Site
  - Praha 5, Czech Republic
    - Research Site
Italy
- - Napoli, 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
- PG
  - Perugia, PG, 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
  - Kristiansand S, 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
- - Bydgoszcz, Poland
    - Research Site
  - Sopot, Poland
    - Research Site
  - Warszawa, Poland
    - Research Site
Slovakia
- - Bratislava, Slovakia
    - Research Site
  - Nové Mesto nad Váhom, Slovakia
    - Research Site
South Africa
- - Bloemfontein, South Africa
    - Research Site
  - Cape Town, South Africa
    - Research Site
  - Johannesburg, South Africa
    - Research Site
  - Pretoria, South Africa
    - Research Site
Sweden
- - Bredbyn, Sweden
    - Research Site
  - Gävle, Sweden
    - Sweden
  - 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
  - Pasadena, Texas, United States
    - Research Site
  - 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.
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.

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
Mean change in the upper GI symptoms (pain, discomfort or
burning in the upper abdomen), rated on a 7-graded severity scale

Secondary Outcome Measures

Outcome Measure
- Mean change in the upper GI symptom score
- The proportion of days with an upper GI symptom score of 'None' at 2 and 4 weeks of treatment.
- Mean upper GI symptom score by day over the duration of the study.
- Cumulative proportion of patients who achieve relief of upper GI symptoms by Week 2 and Week 4.
- Proportions of patients with upper GI symptoms during night, over the duration of the study.
- The proportion of patients with resolution or relief of investigator-recorded symptoms of heartburn, acid regurgitation, nausea & upper abdominal bloating at the 2-week, and 4-week visits.
- The mean change in the three dimensions Reflux, Abdominal pain and Indigestion of the Gastrointestinal Symptom Rating Scale (GSRS)
- Mean change in the three dimensions Emotional distress, Sleep disturbance and Food/Drink problems
- Patient's global evaluation of relief of upper GI symptom (Overall Treatment Evaluation, OTE) at the 2-week, and 4-week visits.
-Short Form-36 (SF-36) score at baseline.

Collaborators and Investigators

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

Sponsor

AstraZeneca

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

December 1, 2000

Primary Completion (Actual)

September 1, 2002

Study Completion (Actual)

September 1, 2002

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

D9617C00003
SH-NEN-0003

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.