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

• Status: Completed
• Trial end date: 2003-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Esomeprazole

Criteria

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)