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

Phase 3

Completed

• Conditions: GERD

• Registration Number: NCT00241540
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-01
• Primary Completion: 2002-08
• Study Completion: 2002-08
• Study First Submitted: 2005-10-18
• Study First Submitted QC: 2005-10-18
• Study First Posted: 2005-10-19
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-21
• Last Update Posted: 2011-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 808

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of esomeprazole versus placebo through 4 weeks of treatment of upper GI symptoms associated with nonsteroidal anti-inflammation

Secondary Outcome Measures

Name	Time	Method
- 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

Trial Locations

Locations (1)

Research Site; 🇪🇸 Zaragoza, Spain