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

Study Overview
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Brief Summary
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This study was a multicentre, double-blind, randomised, placebo-controlled parallel group study consisting of 4 visits over a period of 6 months. The primary variable was to assess the efficacy of esomeprazole 40 mg orally qd (E40) or esomeprazole 20 mg orally qd (E20) versus placebo orally qd after 6 months of treatment for the prevention of relapse of upper GI symptoms associated with NSAID use, including COX-2 selective NSAIDs, in patients receiving daily NSAID therapy.

Official Title
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Efficacy of Esomeprazole 40 mg Once Daily Versus Placebo or Esomeprazole 20 mg Once Daily Versus Placebo in Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs Including COX-2 Selective NSAIDs

Conditions
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GERD

Intervention / Treatment
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* Drug: Esomeprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent. Completed the SH-NEN-0001 study with relief of upper GI symptom. Relief is defined as last 7 days with a diary assessment of None or Minimal, but allowing up to 2 days to be rated as Mild during the 7-day period. A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid arthritis) that requires continuous daily NSAID treatment for at least 6 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 NSAIDs. Daily NSAID treatment dose and type: (Must have been stable for at least 9 weeks prior to inclusion and; Are expected to remain stable for the duration of the study. and; Must be administered orally. If more than one type of NSAID treatment is used, at least one type must be administered orally). Hp negative on Histology performed at baseline endoscopy in the study SHNEN- 0001. Exclusion Criteria: Discontinuation from study SH-NEN-0001 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. Pregnancy or lactation. Women of childbearing potential must maintain effective contraception during the study period as judged by the investigator. Need for continuous concomitant therapy with: (Anticoagulants; Corticosteroids at doses higher than explained under inclusion criterion)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Esomeprazole|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy of esomeprazole 40 mg orally q.d. versus placebo orally q.d. |  |  | 
| and 20 mg q.d. versus placebo orally q.d. through 6 months of treatment for the |  |  | 
| prevention of relapse of upper GI symptom associated with NSAID use in patients |  |  | 
| receiving daily NSAID therapy. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of esomeprazole 40 mg orally q.d. versus placebo orally q.d. and 20 mg orally q.d. versus placebo orally q.d. when administered for 6 months to patients receiving daily NSAID therapy. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSAIDs, Upper GI symptoms