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

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Upper GI Symptoms

NSAIDs

Treatments

Drug: Esomeprazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT00241553

D9617C00004

SH-NEN-0004

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.