Back to resultsEsomeprazole for Relief 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. 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.
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Outcomes
Primary Outcome Measures
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
- 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00241527
Brief Title
Esomeprazole for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
December 2000 (undefined)
Primary Completion Date
September 2002 (Actual)
Study Completion Date
September 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
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.
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
556 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Primary Outcome Measure Information:
Title
Mean change in the upper GI symptoms (pain, discomfort or
Title
burning in the upper abdomen), rated on a 7-graded severity scale
Secondary Outcome Measure Information:
Title
- Mean change in the upper GI symptom score
Title
- The proportion of days with an upper GI symptom score of 'None' at 2 and 4 weeks of treatment.
Title
- Mean upper GI symptom score by day over the duration of the study.
Title
- Cumulative proportion of patients who achieve relief of upper GI symptoms by Week 2 and Week 4.
Title
- Proportions of patients with upper GI symptoms during night, over the duration of the study.
Title
- 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.
Title
- The mean change in the three dimensions Reflux, Abdominal pain and Indigestion of the Gastrointestinal Symptom Rating Scale (GSRS)
Title
- Mean change in the three dimensions Emotional distress, Sleep disturbance and Food/Drink problems
Title
- Patient's global evaluation of relief of upper GI symptom (Overall Treatment Evaluation, OTE) at the 2-week, and 4-week visits.
Title
-Short Form-36 (SF-36) score at baseline.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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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United States
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Phoenix
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Elkhart
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Evansville
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Hollywood
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Butte
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Princeton
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Toms River
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Endwell
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Reading
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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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Nottingham
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Worsley
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Yoxall
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12. IPD Sharing Statement
Learn more about this trial
Esomeprazole for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs
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