Esomeprazole for Relief 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 is a randomised, double-blind, parallel-group and placebo controlled study comparing the efficacy of esomeprazole 40 mg orally qd vs. placebo and esomeprazole 20 mg orally qd vs. placebo when given to patients on continuous use of NSAIDs, including COX-2 selective NSAIDs, for a period of 4 weeks in treatment of relief of upper GI symptoms.

Official title: Efficacy of Esomeprazole 40 mg Once Daily Versus Placebo & Esomeprazole 20 mg Once Daily Versus Placebo in Treatment for Relief 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 versus placebo through 4 weeks of treatment of upper GI symptoms associated with nonsteroidal anti-inflammation

Secondary outcome:

- To assess the safety & tolerability of esomeprazole versus placebo when administered for up to 4 weeks to patients receiving daily NSAID therapy

- To assess the impact of treatment

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

Criteria:

Inclusion Criteria:

- 18 years of age, or older.

- Capable of completing the diary card.

- Ability to complete the HRQL questionnaires.

- A clinical diagnosis of a chronic condition (e. g., osteoarthritis or rheumatoid

arthritis) that requires continuous daily NSAID treatment for at least 7 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 aspirin (>325 mg/day).

- Daily NSAID treatment dose and type: (Must have been stable for at least 4 weeks

prior to baseline endoscopy and; Are expected to remain stable for the duration of the study. and; Must be administered orally for the duration of the study. If more than one type of NSAID treatment is used, at least one type must be given orally).

Exclusion Criteria:

- Current, or history of, gastric or duodenal ulcer

- Current, or history of, esophageal, gastric or duodenal surgery.

- History of GERD, not associated with NSAID use.

- 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, as judged by the investigator.

- Endoscopic Barrett's esophagus(>3 cm) or significant dysplastic changes in the

esophagus

Research Site, Alleur, Belgium

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Starting date: January 2001
Last updated: January 11, 2008