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

Condition(s) targeted: GERD

Intervention: Esomeprazole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Nexium Medical Sciences Director, MD, Study Director, Affiliation: AstraZeneca

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: 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

Study design: Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Efficacy Study

Primary outcome:

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: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Research Site, Alleur, Belgium

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Starting date: February 2001
Last updated: October 19, 2005