Overview

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 theefficacy 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-0003 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

- Are expected to remain stable for the duration of the study.

- 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-0003.

Exclusion Criteria:

- Discontinuation from study SH-NEN-0003

- 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.