Esomeprazole for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs
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|ClinicalTrials.gov Identifier: NCT00241527|
Recruitment Status : Completed
First Posted : October 19, 2005
Last Update Posted : January 24, 2011
|Condition or disease||Intervention/treatment||Phase|
|NSAIDs Upper GI Symptoms||Drug: Esomeprazole||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||556 participants|
|Intervention Model:||Parallel Assignment|
|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 Start Date :||December 2000|
|Actual Primary Completion Date :||September 2002|
|Actual Study Completion Date :||September 2002|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00241527
|Study Director:||AstraZeneca Nexium Medical Sciences Director, MD||AstraZeneca|