Esomeprazole for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of 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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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|
- Mean change in the upper GI symptoms (pain, discomfort or
- burning in the upper abdomen), rated on a 7-graded severity scale
- - 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.
|Study Start Date:||December 2000|
|Study Completion Date:||September 2002|
|Primary Completion Date:||September 2002 (Final data collection date for primary outcome measure)|
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|Study Director:||AstraZeneca Nexium Medical Sciences Director, MD||AstraZeneca|